Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

• Sponsor: Cochlear (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03848910
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).

Condition or Disease	Intervention/Treatment	Phase
Deafness; Sensoneural Single Sided; Conductive Hearing Loss; Mixed Hearing Loss	Device: Investigational device - Sound Processor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
• Actual Study Start Date: Feb 19, 2019
• Actual Primary Completion Date: Apr 23, 2019
• Actual Study Completion Date: Apr 23, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Investigational device - Sound Processor

Device: Investigational device - Sound Processor; At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.

Outcome Measures

Primary Outcome Measures

1. Abbreviated Profile of Hearing Aid Benefit (APHAB) [Day 0 (Visit 1) and after 6 weeks (Visit 3)]

   Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.

2. Speech, Spatial, and Qualities of Hearing Scale (SSQ) [Day 0 and after 6 weeks]

   Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly" is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment.

3. Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2) [Day 0 and after 6 weeks]

   Measuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied. The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant.

4. Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4) [Baseline at visit 1, 6 weeks after study start at visit 3]

   To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.

5. Audiometric Thresholds in Freefield, Individual Frequencies [6 weeks after study start]

   To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.

6. Adaptive Speech Recognition in Noise Ratio [Baseline at visit 1, 6 weeks after study start at visit 3]

   To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in 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. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.

7. Speech in Quiet [Baseline at visit 1, 6 weeks after study start at visit 3]

   To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment.

8. To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor [6 weeks after study start]

   The test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference.

9. To Assess the Subject's Experience Regarding Comfort [Baseline at visit 1, 6 weeks after study start at visit 3]

   Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort.

10. To Assess the Subject's Experience Regarding Usage; Magnet Choice [6 weeks after study start]

    Magnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest.

11. To Assess the Subject's Experience Regarding Usage; Battery Life Time [6 weeks after study start]

    The patient will be asked a question regarding battery life; "How often was the battery changed". A free text field is available for answer.

12. To Assess the Subject's Experience Regarding Usage; Softwear Pad [6 weeks after study start]

    The patient will be asked a question "Did you use a SoftWear Pad in the last 6 weeks". The patient can tick a "Yes" or "No" box.

13. To Assess the Subject's Experience Regarding Usage; Safety Line [6 weeks after study start]

    The patient will be asked a question "Did you use a safety line in the last 6 weeks". The patient can tick a "Yes" or "No" box.

14. To Assess the Subject's Experience Regarding Usage; Wireless Accessories [6 weeks after study start]

    The patient will be asked a question "Did you use a Wireless accessory during the last 6 weeks". The patient can tick a "Yes" or "No" box.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed clinical investigation CBAS5539, and an active user of the Osia System.

• Signed Informed consent.

• Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL.

OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in the good ear.

• Optimally fitted with Osia Sound processor, according to subject's experience prior to inclusion.

Exclusion Criteria:

• Any ongoing soft tissue complication that could significantly affect the use of the Osia 2 Sound Processor during the 6 weeks period

• Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

• Unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the Clinical Investigation Plan (CIP).

• Participation in another clinical investigation with pharmaceutical and/or device.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HEARing CRC550 Swanston Street, Carlton	Melbourne	Victoria	Australia	3053

Sponsors and Collaborators

• Cochlear

Investigators

• Principal Investigator: Robert Cowan, Prof, HEARing CRC550, Carlton, Melbourne

Study Documents (Full-Text)

• Study Protocol - Dec 11, 2018
• Statistical Analysis Plan - May 6, 2019

More Information

Publications

None provided.

• Responsible Party: Cochlear
• ClinicalTrials.gov Identifier: NCT03848910
• Other Study ID Numbers: CBAS5731
• First Posted: Feb 21, 2019
• Last Update Posted: Oct 14, 2021
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Sensorineural

Study Results

Participant Flow

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
Period Title: Overall Study
STARTED	11
COMPLETED	11
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.7 (12.7)
Sex: Female, Male (Count of Participants)
Female	5 45.5%
Male	6 54.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	10 90.9%
More than one race	0 0%
Unknown or Not Reported	1 9.1%
Region of Enrollment (participants) [Number]
Australia	11 100%

Outcome Measures

1. Primary Outcome

Title	Abbreviated Profile of Hearing Aid Benefit (APHAB)
Description	Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.
Time Frame	Day 0 (Visit 1) and after 6 weeks (Visit 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Ease of communication	6.3 (10.1)
Background noise	7.0 (12.6)
Reverberation	5.6 (10.3)
Aversiveness	3.5 (7.5)
Global	6.3 (9.5)

2. Primary Outcome

Title	Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Description	Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly" is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment.
Time Frame	Day 0 and after 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Spatial score	1.0 (1.6)
Quality score	0.061 (1.26)
Speech	0.96 (0.89)
Total	0.68 (0.62)

3. Primary Outcome

Title	Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Description	Measuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied. The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant.
Time Frame	Day 0 and after 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Visit 1: Dimension; not satisfied at all	0 0%
Visit 1: Dimension; not very satisfied	0 0%
Visit 1: Dimension; more or less satisfied	3 27.3%
Visit 1: Dimension; quiet satisfied	4 36.4%
Visit 1: Dimension; very satisfied	4 36.4%
Visit 3: Dimension; not satisfied at all	0 0%
Visit 3: Dimension; not very satisfied	0 0%
Visit 3: Dimension; more or less satisfied	0 0%
Visit 3: Dimension; quiet satisfied	3 27.3%
Visit 3: Dimension; very satisfied	8 72.7%
Visit 1: Weight; not satisfied at all	0 0%
Visit 1: Weight; not very satisfied	0 0%
Visit 1: Weight; more or less satisfied	0 0%
Visit 1: Weight; quiet satisfied	3 27.3%
Visit 1: Weight; very satisfied	8 72.7%
Visit 3: Weight; not satisfied at all	0 0%
Visit 3: Weight; not very satisfied	0 0%
Visit 3: Weight; more or less satisfied	0 0%
Visit 3: Weight; quiet satisfied	0 0%
Visit 3: Weight; very satisfied	11 100%
Visit 1: Adjustment; not satisfied at all	0 0%
Visit 1: Adjustment; not very satisfied	0 0%
Visit 1: Adjustment; more or less satisfied	2 18.2%
Visit 1: Adjustment; quiet satisfied	3 27.3%
Visit 1: Adjustment; very satisfied	6 54.5%
Visit 3: Adjustment; not satisfied at all	0 0%
Visit 3: Adjustment; not very satisfied	0 0%
Visit 3: Adjustment; more or less satisfied	1 9.1%
Visit 3: Adjustment; quiet satisfied	2 18.2%
Visit 3: Adjustment; very satisfied	8 72.7%
Visit 1: Safety; not satisfied at all	0 0%
Visit 1: Safety; not very satisfied	0 0%
Visit 1: Safety; more or less satisfied	3 27.3%
Visit 1: Safety; quiet satisfied	1 9.1%
Visit 1: Safety; very satisfied	7 63.6%
Visit 3: Safety; not satisfied at all	0 0%
Visit 3: Safety; not very satisfied	1 9.1%
Visit 3: Safety; more or less satisfied	2 18.2%
Visit 3: Safety; quiet satisfied	2 18.2%
Visit 3: Safety; very satisfied	6 54.5%
Visit 1: Durability; not satisfied at all	0 0%
Visit 1: Durability; not very satisfied	0 0%
Visit 1: Durability; more or less satisfied	1 9.1%
Visit 1: Durability; quiet satisfied	4 36.4%
Visit 1: Durability; very satisfied	6 54.5%
Visit 3: Durability; not satisfied at all	0 0%
Visit 3: Durability; not very satisfied	0 0%
Visit 3: Durability; more or less satisfied	1 9.1%
Visit 3: Durability; quiet satisfied	4 36.4%
Visit 3: Durability; very satisfied	6 54.5%
Visit 1: Easy of use; not satisfied at all	0 0%
Visit 1: Easy of use; not very satisfied	0 0%
Visit 1: Easy of use; more or less satisfied	3 27.3%
Visit 1: Easy of use; quiet satisfied	3 27.3%
Visit 1: Easy of use; very satisfied all	5 45.5%
Visit 3: Easy of use; not satisfied at all	0 0%
Visit 3: Easy of use; not very satisfied	0 0%
Visit 3: Easy of use; more or less satisfied	1 9.1%
Visit 3: Easy of use; quiet satisfied	3 27.3%
Visit 3: Easy of use; very satisfied all	7 63.6%
Visit 1: Comfort; not satisfied at all	0 0%
Visit 1: Comfort; not very satisfied	0 0%
Visit 1: Comfort; more or less satisfied	0 0%
Visit 1: Comfort; quiet satisfied	3 27.3%
Visit 1: Comfort; very satisfied	8 72.7%
Visit 3: Comfort; not satisfied at all	0 0%
Visit 3: Comfort; not very satisfied	0 0%
Visit 3: Comfort; more or less satisfied	0 0%
Visit 3: Comfort; quiet satisfied	2 18.2%
Visit 3: Comfort; very satisfied	9 81.8%
Visit 1: Effectiveness; not satisfied at all	0 0%
Visit 1: Effectiveness; not very satisfied	0 0%
Visit 1: Effectiveness; more or less satisfied	1 9.1%
Visit 1: Effectiveness; quiet satisfied	7 63.6%
Visit 1: Effectiveness; very satisfied	3 27.3%
Visit 3: Effectiveness; not satisfied at all	0 0%
Visit 3: Effectiveness; not very satisfied	0 0%
Visit 3: Effectiveness; more or less satisfied	1 9.1%
Visit 3: Effectiveness; quiet satisfied	3 27.3%
Visit 3: Effectiveness; very satisfied	7 63.6%
Visit 1: Important item, Dimensions	2 18.2%
Visit 1: Important item, Weight	1 9.1%
Visit 1: Important item, Adjustments	2 18.2%
Visit 1: Important item, Safety	0 0%
Visit 1: Important item, Durability	5 45.5%
Visit 1: Important item, Easy of use	5 45.5%
Visit 1: Important item, Comfort	7 63.6%
Visit 1: Important item, Effectiveness	11 100%
Visit 3: Important item, Dimensions	4 36.4%
Visit 3: Important item, Weight	0 0%
Visit 3: Important item, Adjustments	1 9.1%
Visit 3: Important item, Safety	1 9.1%
Visit 3: Important item, Durability	5 45.5%
Visit 3: Important item, Easy of use	4 36.4%
Visit 3: Important item, Comfort	7 63.6%
Visit 3: Important item, Effectiveness	11 100%

4. Primary Outcome

Title	Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
Description	To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Time Frame	Baseline at visit 1, 6 weeks after study start at visit 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Mean (Standard Deviation) [dB]	-2.5 (2.4)

5. Primary Outcome

Title	Audiometric Thresholds in Freefield, Individual Frequencies
Description	To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
250 Hz	-2.3 (4.7)
500 Hz	-3.6 (5.1)
750 Hz	-6.4 (3.9)
1000 Hz	-3.6 (3.9)
1500 Hz	-3.6 (6.0)
2000 Hz	-1.2 (3.4)
3000 Hz	-4.1 (3.8)
4000 Hz	-0.9 (5.4)
6000 Hz	-4.6 (4.2)
8000 Hz	-1.8 (14.7)

6. Primary Outcome

Title	Adaptive Speech Recognition in Noise Ratio
Description	To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in 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. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Time Frame	Baseline at visit 1, 6 weeks after study start at visit 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Visit 1	-1.3 (1.2)
Visit 3	-1.2 (1.4)

7. Primary Outcome

Title	Speech in Quiet
Description	To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment.
Time Frame	Baseline at visit 1, 6 weeks after study start at visit 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
50 dB visit 1	82.5 (6.8)
50 dB visit 3	83.3 (7.2)
65 dB visit 1	93.7 (2.4)
65 dB visit 3	96.9 (2.4)
80 dB visit 1	94.4 (4.1)
80 dB visit 3	96.9 (2.6)

8. Primary Outcome

Title	To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
Description	The test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
No preference	0 0%
Precursor sound processor	0 0%
Investigational device	11 100%

9. Primary Outcome

Title	To Assess the Subject's Experience Regarding Comfort
Description	Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort.
Time Frame	Baseline at visit 1, 6 weeks after study start at visit 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Precursor sound processor	84.9 (16.8)
Investigational device	87.5 (7.5)

10. Primary Outcome

Title	To Assess the Subject's Experience Regarding Usage; Magnet Choice
Description	Magnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Strength 1	1 9.1%
Strength 2	3 27.3%
Strength 3	3 27.3%
Strength 4	4 36.4%

11. Primary Outcome

Title	To Assess the Subject's Experience Regarding Usage; Battery Life Time
Description	The patient will be asked a question regarding battery life; "How often was the battery changed". A free text field is available for answer.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Every day	2 18.2%
Two work days (16 hours)	1 9.1%
1.5 days	2 18.2%
Every 2 days	3 27.3%
Every 3 days	1 9.1%
Every 3-4 days	1 9.1%
1-2 times a week	1 9.1%

12. Primary Outcome

Title	To Assess the Subject's Experience Regarding Usage; Softwear Pad
Description	The patient will be asked a question "Did you use a SoftWear Pad in the last 6 weeks". The patient can tick a "Yes" or "No" box.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Yes	2 18.2%
No	9 81.8%

13. Primary Outcome

Title	To Assess the Subject's Experience Regarding Usage; Safety Line
Description	The patient will be asked a question "Did you use a safety line in the last 6 weeks". The patient can tick a "Yes" or "No" box.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Yes	9 81.8%
No	2 18.2%

14. Primary Outcome

Title	To Assess the Subject's Experience Regarding Usage; Wireless Accessories
Description	The patient will be asked a question "Did you use a Wireless accessory during the last 6 weeks". The patient can tick a "Yes" or "No" box.
Time Frame	6 weeks after study start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
Measure Participants	11
Yes	11 100%
No	0 0%

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Investigational Device - Sound Processor
Arm/Group Description	Investigational device - Sound Processor: At visit 1 the subjects completed self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects then received the Investigational device (Sound Processor) which was used during the following 6 weeks. At visit 3 the subjects completed self-reported assessments regarding Investigational device and participated in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject decided their preferred choice made by selection between Investigational device and the comparator.
All Cause Mortality
	Investigational Device - Sound Processor
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	Investigational Device - Sound Processor
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Investigational Device - Sound Processor
	Affected / at Risk (%)	# Events
Total	4/11 (36.4%)
Ear and labyrinth disorders
Fluid in middle ear	1/11 (9.1%)	1
Fall due to SCCD	1/11 (9.1%)	1
Infections and infestations
Upper respiratory infection	1/11 (9.1%)	1
Mastoid cavity infection	1/11 (9.1%)	1
Skin and subcutaneous tissue disorders
Skin irritation-test ear	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Institution must give a copy of any proposed Publication to the Sponsor at least 40 days before forwarding it to any person that is not bound by the confidentiality obligations The Sponsor may, within that 40-day period: provide comments; request delay of Publication for no more than 120 days, or request that the Discloser remove specified Confidential Information from the Publication.