Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)

Sponsor

Cochlear Bone Anchored Solutions (Industry)

Overall Status

Completed

CT.gov ID

NCT02022085

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery:

to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband;
to evaluate the mid- and long-term safety of the Baha Attract System.

Condition or Disease	Intervention/Treatment	Phase
Deafness Hearing Loss Hearing Loss, Conductive	Device: Baha Attract System	N/A

Detailed Description

This investigation was designed to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that were candidates for Baha surgery.

The investigation was performed in an open design since it was not possible to perform the investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing tests, are standard audiological procedures that are routinely used in daily clinical practice at hospitals worldwide for evaluation of hearing performance in hearing impaired patients. The primary efficacy evaluation, audiometric thresholds, renders comparable results across different sites and countries as it is not a language-specific test. Language-specific audiological tests were performed as secondary efficacy evaluations; to enable comparison of data across sites, validated word lists were used at all sites and equivalent speaker configurations (speech from front, noise from behind) and test procedures (same noise and adaptive speech levels, etc) were used.

For the primary evaluation in the investigation, the Baha Attract System was compared to the pre-operative unaided situation, as the intended use of the system is to improve hearing performance in patients with conductive or mixed hearing loss or single-sided sensorineural deafness. Audiological test results with the Baha Attract System were also compared against results obtained with the same Sound Processor on a Baha Softband. Use of the Sound Processor on a Softband is a standard procedure that is routinely used as a pre-operative test prior to bone conduction hearing implant surgery. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome and to choose a suitable Sound Processor.

The generic and hearing-specific quality of life questionnaires used in the investigation (HUI3, APHAB, SSQ) are validated scales that have been frequently used and reported in the literature.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Baha Attract System This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)	Device: Baha Attract System The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Arm

Intervention/Treatment

Experimental: Baha Attract System

This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)

Device: Baha Attract System

The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Outcome Measures

Primary Outcome Measures

Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract [Baseline (unaided) before surgery, 6, 12 and 24 months after surgery]
The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract [Baseline (unaided) before surgery, 24 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract [Baseline (unaided) before surgery, 12 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract [Baseline (unaided) before surgery, 6 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Secondary Outcome Measures

Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract [Baseline (unaided) before surgery, 6, 12 and 24 months after surgery]
The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. Manchester and Birmingham are excluded from this analysis due to incorrect set up.
Speech in Quiet, Baha Attract Versus Unaided [Baseline before surgery, 6, 12 and 24 months after surgery]
The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract [Baseline before surgery, 6, 12 and 24 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband [Baseline (aided) before surgery, 6 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband [Baseline (aided) before surgery, 12 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband [Baseline (aided) before surgery, 24 months after surgery]
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband [Baseline (aided) before surgery, 6, 12 and 24 months after surgery]
The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.
Speech in Quiet: Baha Attract Versus Sound Processor on Softband [Baseline (aided) before surgery, 6, 12 and 24 months after surgery]
The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Health Utility Index (HUI) [Baseline (unaided) before surgery, 6 and 24 months after surgery]
Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.
Abbreviated Profile of Hearing Aid Benefit (APHAB) [Baseline before surgery, 6 and 24 months after surgery]
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.
Speech, Spatial and Qualities of Hearing Scale (SSQ) [Baseline before surgery, 6 and 24 months after surgery]
Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time to Perform Surgery [Visit 2 (Surgery)]
Time of first incision to time of last suture
Tissue Reduction Performed During Surgery [Visit 2 (surgery)]
Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm
Implant Stability [Visit 2 (surgery)]
Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability
Magnetic Force [4, 6, 12 weeks, 6, 12 and 24 months]
To investigate if the magnetic force required for sound processor magnet retention will change over time
Sound Processor Magnet Choice [4, 6, 12 weeks, 6, 12 and 24 months]
To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.
Pain & Discomfort [Week 6, Week 12, Month 6, Month 12, Month 24]
Degree of pain and discomfort.
Numbness When Tested With a Pin [Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24]
Degree of numbness when tested with a pin
Numbness When Tested With a Cotton Swab [Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24]
Degree of numbness when tested with a Cotton Swab

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult subject, i.e. ≥ 18 years of age

Conductive or mixed hearing loss in the ear to be implanted:

Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).

Single-sided sensorineural deafness (SSD):

European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.

US sites: Air conduction thresholds with a pure tone average PTA4 of 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS.

No previous bone conduction implant on the side of the skull to be implanted. Signed informed consent.

Exclusion Criteria:

Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (however, bilateral hearing loss is not an exclusion criterion).

Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness.

Less than 3 mm soft tissue thickness at the planned implant site. Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.

Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).

Uncontrolled diabetes as judged by the investigator. Condition that may have an impact on the outcome of the investigation as judged by the investigator.

Unable to follow investigational procedures (e.g. to complete quality of life scales).

Participation in another investigation with pharmaceuticals and/or medical device.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Doug Backhus	Seattle	Washington	United States	98122
2	Christina Runge	Milwaukee	Wisconsin	United States	53227
3	Dr. Myrthe Hol	Nijmegen		Netherlands
4	World Hearing Center Institute of Physiology and Pathology of Hearing	Kajetany	Nadarzyn	Poland	05-830
5	Peter Monksfield	Birmingham		United Kingdom
6	Kevin Green	Manchester		United Kingdom

Sponsors and Collaborators

Cochlear Bone Anchored Solutions

Investigators

Study Director: Johan Blechert, M.Sc, Cochlear Bone Anchored Solutions AB

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Cochlear Bone Anchored Solutions

ClinicalTrials.gov Identifier:

NCT02022085

Other Study ID Numbers:

CBAS5477

First Posted:

Dec 27, 2013

Last Update Posted:

Oct 12, 2018

Last Verified:

Oct 1, 2018

Additional relevant MeSH terms:

Hearing Loss

Deafness

Hearing Loss, Conductive

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Period Title: Overall Study
STARTED	54
COMPLETED	53
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Overall Participants	54
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.1 (13.6)
Sex: Female, Male (Count of Participants)
Female	33 61.1%
Male	21 38.9%
Region of Enrollment (participants) [Number]
Netherlands	23 42.6%
United States	1 1.9%
Poland	14 25.9%
United Kingdom	16 29.6%
Type of hearing loss (participants) [Number]
Conductive hearing loss	39 72.2%
Single-sided sensorineural deafness	15 27.8%

Outcome Measures

1. Primary Outcome

Title	Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
Description	The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (unaided) before surgery, 6, 12 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
PTA4 6 months, Baha Attract vs Unaided	-21.0 (10.4)
PTA4 12 months, Baha Attract vs Baha Attract	-20.9 (10.4)
PTA4 24 months, Baha Attract vs Unaided	-21.5 (8.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	PTA4 6 months with Baha Attract vs Unaided
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	PTA4 12 months with Baha Attract vs Unaided
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	PTA4 24 months with Baha Attract vs Unaided
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

2. Primary Outcome

Title	Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Description	The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (unaided) before surgery, 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	46
Change of Threshold value at 250 Hz	-19.9 (11.0)
Change of Threshold value at 500 Hz	-25.3 (9.6)
Change of Threshold value at 1000 Hz	-28.0 (12.4)
Change of Threshold value at 2000 Hz	-19.6 (11.8)
Change of Threshold value at 3000 Hz	-18.4 (10.9)
Change of Threshold value at 4000 Hz	13.2 (12.0)
Change of Threshold value at 6000 Hz	-8.67 (8.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Baha Attract after 24 months vs Unaided situation Pre-Op
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All comparisons to the Unaided situation were p=<0.0001.
	Method	Fisher's non-parametric permutation test
	Comments

3. Primary Outcome

Title	Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Description	The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (unaided) before surgery, 12 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	51
Change of Threshold value at 250 Hz	-18.5 (14.3)
Change of Threshold value at 500 Hz	-26.0 (13.0)
Change of Threshold value at 1000 Hz	-26.5 (14.2)
Change of Threshold value at 2000 Hz	-18.5 (13.5)
Change of Threshold value at 3000 Hz	-16.3 (13.2)
Change of Threshold value at 4000 Hz	-12.5 (12.2)
Change of Threshold value at 6000 Hz	-7.25 (11.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Baha Attract after 12 months vs Unaided situation Pre-Op
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All comparisons to the Unaided situation were p=<0.0001.
	Method	Fisher's non-parametric permutation test
	Comments

4. Primary Outcome

Title	Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Description	The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (unaided) before surgery, 6 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
Change of Threshold value at 250 Hz	-16.9 (12.9)
Change of Threshold value at 500 Hz	-26.6 (12.8)
Change of Threshold value at 1000 Hz	-26.4 (14.1)
Change of Threshold value at 2000 Hz	-18.7 (12.1)
Change of Threshold value at 3000 Hz	-16.9 (12.7)
Change of Threshold value at 4000 Hz	-12.3 (10.6)
Change of Threshold value at 6000 Hz	-7.04 (8.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Baha Attract after 6 months vs Unaided situation Pre-Op
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All comparisons to the Unaided situation were p=<0.0001.
	Method	Fisher's non-parametric permutation test
	Comments

5. Secondary Outcome

Title	Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
Description	The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. Manchester and Birmingham are excluded from this analysis due to incorrect set up.
Time Frame	Baseline (unaided) before surgery, 6, 12 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention. Adaptive Speech in Noise analysis excluded subjects from Birmingham and Manchester clinics due to incorrect set up.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	36
SNR 6 months, Baha Attract vs Unaided	-4.30 (5.64)
SNR 12 months, Baha Attract vs Unaided	4.79 (6.17)
SNR 24 months, Baha Attract vs Unaided	-4.47 (6.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Speech in Noise, 6 months Baha Attract vs Unaided
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Speech in Noise, 12 months Baha Attract vs Unaided
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Speech in Noise, 24 months Baha Attract vs Unaided
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

6. Secondary Outcome

Title	Speech in Quiet, Baha Attract Versus Unaided
Description	The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Time Frame	Baseline before surgery, 6, 12 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
6 months: Speech in quiet at 50dB	52.1 (29.2)
6 months: Speech in quiet at 65dB	43.4 (31.5)
6 months: Speech in quiet at 80dB	13.3 (20.6)
12 months: Speech in quiet at 50dB	50.7 (30.2)
12 months: Speech in quiet at 65dB	45.5 (31.4)
12 months: Speech in quiet at 80dB	13.9 (21.2)
24 months: Speech in quiet at 50dB	40.4 (33.3)
24 months: Speech in quiet at 65dB	43.3 (29.9)
24 months: Speech in quiet at 80dB	14.0 (20.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Speech in quiet at 50dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Speech in quiet at 65dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Speech in quiet at 80dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months: Speech in quiet at 50dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months: Speech in quiet at 65dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months: Speech in quiet at 80dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Speech in quiet at 50dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Speech in quiet at 65dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Speech in quiet at 80dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

7. Secondary Outcome

Title	Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
Description	The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline before surgery, 6, 12 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
6 months vs Softband: PTA4	-0.62 (5.138)
12 months vs Softband: PTA4	0.196 (6.719)
24 months vs Softband: PTA4	-0.136 (6.472)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months with Baha Attract vs Softband: change in PTA4
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months with Baha Attract vs Softband: change in PTA4
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months with Baha Attract vs Softband: change in PTA4
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

8. Secondary Outcome

Title	Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
Description	The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (aided) before surgery, 6 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
6 months: Change of Threshold value at 250 Hz	-1.30 (9.77)
6 months: Change of Threshold value at 500 Hz	-4.17 (7.99)
6 months: Change of Threshold value at 1000 Hz	-1.11 (6.49)
6 months: Change of Threshold value at 2000 Hz	-0.463 (7.022)
6 months: Change of Threshold value at 3000 Hz	2.69 (9.40)
6 months: Change of Threshold value at 4000 Hz	3.24 (9.07)
6 months: Change of Threshold value at 6000 Hz	5.56 (9.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	250Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	500Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	1000Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	2000Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	3000Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	4000Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6000Hz: 6 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

9. Secondary Outcome

Title	Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
Description	The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (aided) before surgery, 12 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	51
12 months: Change of Threshold value at 250 Hz	-2.55 (11.15)
12 months: Change of Threshold value at 500 Hz	-2.84 (10.74)
12 months: Change of Threshold value at 1000 Hz	-0.392 (6.989)
12 months: Change of Threshold value at 2000 Hz	0.392 (9.265)
12 months: Change of Threshold value at 3000 Hz	4.02 (11.53)
12 months: Change of Threshold value at 4000 Hz	3.63 (11.84)
12 months: Change of Threshold value at 6000 Hz	5.59 (11.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	250Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	500Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.066
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	1000Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	2000Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	3000Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	4000Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6000Hz: 12 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0013
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

10. Secondary Outcome

Title	Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
Description	The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time Frame	Baseline (aided) before surgery, 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	46
24 months: Change of Threshold value at 250 Hz	-3.67 (8.35)
24 months: Change of Threshold value at 500 Hz	-1.74 (10.23)
24 months: Change of Threshold value at 1000 Hz	-1.20 (6.34)
24 months: Change of Threshold value at 2000 Hz	-0.761 (8.690)
24 months: Change of Threshold value at 3000 Hz	2.61 (9.23)
24 months: Change of Threshold value at 4000 Hz	3.15 (11.17)
24 months: Change of Threshold value at 6000 Hz	5.22 (11.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	250Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0051
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	500Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	1000Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	2000Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.57
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	3000Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.064
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	4000Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.064
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6000Hz: 24 months with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0051
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

11. Secondary Outcome

Title	Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
Description	The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.
Time Frame	Baseline (aided) before surgery, 6, 12 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention. Speech in Noise analysis excludes patients from Birmingham and Manchester due to incorrect set up.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	38
6 months: Speech in Noise	-0.508 (4.173)
12 months: Speech in Noise	-1.05 (4.75)
24 months: Speech in Noise	-0.739 (4.106)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Speech in Noise with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months: Speech in Noise with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Speech in Noise with Baha Attract vs Softband
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

12. Secondary Outcome

Title	Speech in Quiet: Baha Attract Versus Sound Processor on Softband
Description	The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Time Frame	Baseline (aided) before surgery, 6, 12 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
6 months: Speech in quiet at 50dB	2.74 (29.94)
6 months: Speech in quiet at 65dB	-2.11 (10.62)
6 months: Speech in quiet at 80dB	-0.33 (5.00)
12 months: Speech in quiet at 50dB	0.373 (27.201)
12 months: Speech in quiet at 65dB	-2.69 (11.16)
12 months: Speech in quiet at 80dB	-0.961 (8.457)
24 months: Speech in quiet at 50dB	-11.6 (32.6)
24 months: Speech in quiet at 65dB	-5.67 (16.48)
24 months: Speech in quiet at 80dB	-0.696 (8.178)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months Speech in Quiet at 50dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months Speech in Quiet at 65dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months Speech in Quiet at 80dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months Speech in Quiet at 50dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months Speech in Quiet at 65dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.094
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	12 months Speech in Quiet at 80dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months Speech in Quiet at 50dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.021
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months Speech in Quiet at 65dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months Speech in Quiet at 80dB
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

13. Secondary Outcome

Title	Health Utility Index (HUI)
Description	Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.
Time Frame	Baseline (unaided) before surgery, 6 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	53
6 months: Comprehensive health state	0.063 (0.249)
6 months: Vision	-0.003 (0.033)
6 months: Hearing	0.111 (0.321)
6 months: Speech	0.045 (0.153)
6 months: Ambulation	-0.016 (0.067)
6 months: Dexterity	-0.021 (0.108)
6 months: Emotion	0.017 (0.152)
6 months: Cognition	0.005 (0.158)
6 months: Pain	0.020 (0.123)
24 months: Comprehensive health state	0.069 (0.240)
24 months: Vision	0.002 (0.015)
24 months: Hearing	0.119 (0.358)
24 months: Speech	0.051 (0.135)
24 months: Ambulation	-0.015 (0.076)
24 months: Dexterity	-0.025 (0.151)
24 months: Emotion	0.014 (0.089)
24 months: Cognition	0.003 (0.134)
24 months: Pain	0.040 (0.117)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Comprehensive health state
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.088
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Vision
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Hearing
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Speech
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Ambulation
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Dexterity
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Emotion
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Cognition
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months change in Pain
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Comprehensive health state
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.088
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Vision
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Hearing
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.045
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Speech
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Ambulation
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Dexterity
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Wilcoxan Signed Rank Test
	Comments	Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Emotion
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Cognition
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months change in Pain
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

14. Secondary Outcome

Title	Abbreviated Profile of Hearing Aid Benefit (APHAB)
Description	Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.
Time Frame	Baseline before surgery, 6 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	53
6 months: Ease of communication	20.4 (24.9)
6 months: Background noise	26.3 (20.6)
6 months: Reverberation	22.0 (19.0)
6 months: Aversiveness	1.32 (23.45)
6 months: Global	22.9 (18.1)
24 months: Ease of communication	18.7 (26.3)
24 months: Background noise	23.7 (20.4)
24 months: Reverberation	20.8 (19.9)
24 months: Aversiveness	-0.596 (19.646)
24 months: Global	21.1 (18.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Ease of communication
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Background noise
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Reverberation
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Aversiveness
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	6 months: Global
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Ease of communication
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Background noise
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Reverberation
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Aversiveness
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	24 months: Global
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

15. Secondary Outcome

Title	Speech, Spatial and Qualities of Hearing Scale (SSQ)
Description	Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time Frame	Baseline before surgery, 6 and 24 months after surgery

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	53
Speech: Change from pre-op to 6 months	2.49 (1.67)
Spatial: Change from pre-op to 6 months	1.87 (1.90)
Qualities: Change from pre-op to 6 months	1.68 (1.36)
Speech: Change from pre-op to 24 months	2.07 (1.57)
Spatial: Change from pre-op to 24 months	1.36 (1.74)
Qualities: Change from pre-op to 24 months	1.30 (1.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Speech: Change from pre-op to 6 months
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Spatial: Change from pre-op to 6 months
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Qualities: Change from pre-op to 6 months
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Speech: Change from pre-op to 24 months
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Spatial: Change from pre-op to 24 months
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Baha Attract System
	Comments	Qualities: Change from pre-op to 24 months
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher's non-parametric permutation test
	Comments

16. Secondary Outcome

Title	Time to Perform Surgery
Description	Time of first incision to time of last suture
Time Frame	Visit 2 (Surgery)

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
Mean (Standard Deviation) [Minutes]	38.7 (10.7)

17. Secondary Outcome

Title	Tissue Reduction Performed During Surgery
Description	Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm
Time Frame	Visit 2 (surgery)

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; all patients who received surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
Tissue thinning	12 22.2%
No tissue thinning	42 77.8%

18. Secondary Outcome

Title	Implant Stability
Description	Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability
Time Frame	Visit 2 (surgery)

Outcome Measure Data

Analysis Population Description
Intention-to-treat (ITT) population; includes all patients who received surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
Mean (Standard Deviation) [units on a scale]	77.3 (9.0)

19. Secondary Outcome

Title	Magnetic Force
Description	To investigate if the magnetic force required for sound processor magnet retention will change over time
Time Frame	4, 6, 12 weeks, 6, 12 and 24 months

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
4 weeks	1.01 (0.40)
6 weeks	1.07 (0.33)
12 weeks	1.15 (0.41)
6 months	1.16 (0.42)
12 months	1.15 (0.38)
24 months	1.09 (0.41)

20. Secondary Outcome

Title	Sound Processor Magnet Choice
Description	To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.
Time Frame	4, 6, 12 weeks, 6, 12 and 24 months

Outcome Measure Data

Analysis Population Description
Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6, 12 and 24 one patient had left the study.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
SPM 6	19 35.2%
SPM 5	19 35.2%
SPM 4	9 16.7%
SPM 3	6 11.1%
SPM 2	1 1.9%
SPM 1	0 0%
SPM 6	11 20.4%
SPM 5	10 18.5%
SPM 4	16 29.6%
SPM 3	13 24.1%
SPM 2	2 3.7%
SPM 1	1 1.9%
SPM 6	6 11.1%
SPM 5	12 22.2%
SPM 4	11 20.4%
SPM 3	15 27.8%
SPM 2	9 16.7%
SPM 1	0 0%
SPM 6	5 9.3%
SPM 5	9 16.7%
SPM 4	12 22.2%
SPM 3	18 33.3%
SPM 2	9 16.7%
SPM 1	0 0%
SPM 6	6 11.1%
SPM 5	11 20.4%
SPM 4	12 22.2%
SPM 3	14 25.9%
SPM 2	8 14.8%
SPM 1	1 1.9%
SPM 6	5 9.3%
SPM 5	8 14.8%
SPM 4	5 9.3%
SPM 3	17 31.5%
SPM 2	9 16.7%
SPM 1	2 3.7%

21. Secondary Outcome

Title	Pain & Discomfort
Description	Degree of pain and discomfort.
Time Frame	Week 6, Week 12, Month 6, Month 12, Month 24

Outcome Measure Data

Analysis Population Description
Safety population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
No Discomfort or Pain	21 38.9%
Slight Discomfort or Pain	15 27.8%
Discomfort or Pain	15 27.8%
Excessive Discomfort or Pain	2 3.7%
No Discomfort or Pain	24 44.4%
Slight Discomfort or Pain	16 29.6%
Discomfort or Pain	11 20.4%
Excessive Discomfort or Pain	2 3.7%
No Discomfort or Pain	33 61.1%
Slight Discomfort or Pain	15 27.8%
Discomfort or Pain	5 9.3%
Excessive Discomfort or Pain	0 0%
No Discomfort or Pain	37 68.5%
Slight Discomfort or Pain	11 20.4%
Discomfort or Pain	4 7.4%
Excessive Discomfort or Pain	0 0%
No Discomfort or Pain	40 74.1%
Slight Discomfort or Pain	4 7.4%
Discomfort or Pain	3 5.6%
Excessive Discomfort or Pain	0 0%

22. Secondary Outcome

Title	Numbness When Tested With a Pin
Description	Degree of numbness when tested with a pin
Time Frame	Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24

Outcome Measure Data

Analysis Population Description
Safety population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
No Numbness	12 22.2%
Numbness within 2cm of Implant	9 16.7%
Numbness within & beyond 2cm from Implant	33 61.1%
No Numbness	15 27.8%
Numbness within 2cm of Implant	7 13%
Numbness within & beyond 2cm from Implant	32 59.3%
No Numbness	21 38.9%
Numbness within 2cm of Implant	3 5.6%
Numbness within & beyond 2cm from Implant	29 53.7%
No Numbness	33 61.1%
Numbness within 2cm of Implant	5 9.3%
Numbness within & beyond 2cm from Implant	15 27.8%
No Numbness	42 77.8%
Numbness within 2cm of Implant	3 5.6%
Numbness within & beyond 2cm from Implant	7 13%
No Numbness	45 83.3%
Numbness within 2cm of Implant	3 5.6%
Numbness within & beyond 2cm from Implant	4 7.4%
No Numbness	45 83.3%
Numbness within 2cm of Implant	0 0%
Numbness within & beyond 2cm from Implant	1 1.9%

23. Secondary Outcome

Title	Numbness When Tested With a Cotton Swab
Description	Degree of numbness when tested with a Cotton Swab
Time Frame	Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24

Outcome Measure Data

Analysis Population Description
Safety population; includes all patients who received the surgical intervention.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Measure Participants	54
No Numbness	13 24.1%
Numbness within 2 cm from implant	9 16.7%
Numbness within & beyond 2cm from Implant	32 59.3%
No Numbness	18 33.3%
Numbness within 2 cm from implant	6 11.1%
Numbness within & beyond 2cm from Implant	30 55.6%
No Numbness	23 42.6%
Numbness within 2 cm from implant	2 3.7%
Numbness within & beyond 2cm from Implant	28 51.9%
No Numbness	31 57.4%
Numbness within 2 cm from implant	6 11.1%
Numbness within & beyond 2cm from Implant	16 29.6%
No Numbness	43 79.6%
Numbness within 2 cm from implant	2 3.7%
Numbness within & beyond 2cm from Implant	7 13%
No Numbness	44 81.5%
Numbness within 2 cm from implant	3 5.6%
Numbness within & beyond 2cm from Implant	5 9.3%
No Numbness	42 77.8%
Numbness within 2 cm from implant	3 5.6%
Numbness within & beyond 2cm from Implant	1 1.9%

Adverse Events

	Baha Attract System
Time Frame	24 months
Adverse Event Reporting Description	The AEs were encoded according to the CTCAE dictionary and only to the SOC term.

Arm/Group Title	Baha Attract System
Arm/Group Description	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	1/54 (1.9%)
Serious Adverse Events
	Baha Attract System
	Affected / at Risk (%)	# Events
Total	13/54 (24.1%)
Blood and lymphatic system disorders
Embolisation of the Splenic Artery from pancreatitis	1/54 (1.9%)	1
Ear and labyrinth disorders
Increase of Meniere Attacks	1/54 (1.9%)	1
Progression of Hearing Loss	1/54 (1.9%)	1
Gastrointestinal disorders
Pancreatitis	1/54 (1.9%)	1
General disorders
Increase in instability of knee prosthesis	1/54 (1.9%)	1
Hepatobiliary disorders
Decompensated Alcoholic Liver Disease	1/54 (1.9%)	1
Infections and infestations
Infection	1/54 (1.9%)	1
Injury, poisoning and procedural complications
Broken Ankle	1/54 (1.9%)	1
Pain/Discomfort	1/54 (1.9%)	1
Musculoskeletal and connective tissue disorders
Dequervian	1/54 (1.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma	1/54 (1.9%)	1
Pregnancy, puerperium and perinatal conditions
Patient was addmitted to the hospital due to childbirth	1/54 (1.9%)	1
Surgical and medical procedures
Surgery for Baha Attract on other ear	1/54 (1.9%)	1
Vascular disorders
Increase in Occlusive Arterial Disease	1/54 (1.9%)	1
Other (Not Including Serious) Adverse Events
	Baha Attract System
	Affected / at Risk (%)	# Events
Total	29/54 (53.7%)
Ear and labyrinth disorders
Ear and Labyrinth Disorders	6/54 (11.1%)	9
Gastrointestinal disorders
Gastrointestinal Disorders	4/54 (7.4%)	5
General disorders
General Disorders and Administration Site Conditions	10/54 (18.5%)	10
Infections and infestations
Infections and Infestation	14/54 (25.9%)	21
Injury, Poisoning and Procedural Complications	5/54 (9.3%)	5
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders	4/54 (7.4%)	4
Nervous system disorders
Nervous System Disorders	5/54 (9.3%)	5
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	3/54 (5.6%)	3
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders	7/54 (13%)	7
Predefined event: Pressure related Skin Complications	6/54 (11.1%)	6
Predefined event: Pain/Discomfort	24/54 (44.4%)	37
Vascular disorders
Vascular Disorders	3/54 (5.6%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Professor Emmanuel Mylanus
Organization	Radboud University Medical Centre, Nijmegen, The Netherlands
Phone	+31 24 361 1111
Email	Emmanuel.Mylanus@radboudumc.nl

Responsible Party:

Cochlear Bone Anchored Solutions

ClinicalTrials.gov Identifier:

NCT02022085

Other Study ID Numbers:

CBAS5477

First Posted:

Dec 27, 2013

Last Update Posted:

Oct 12, 2018

Last Verified:

Oct 1, 2018