Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Sponsor
Cochlear (Industry)
Overall Status
Completed
CT.gov ID
NCT04041700
Collaborator
Statistiska Konsultgruppen (Other)
29
3
1
13.3
9.7
0.7
Study Details
Study Description
Brief Summary
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
Actual Study Start Date
:
Aug 16, 2019
Actual Primary Completion Date
:
Jun 19, 2020
Actual Study Completion Date
:
Sep 24, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Osia 2 system
|
Device: Osia 2 system
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
|
Outcome Measures
Primary Outcome Measures
- Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds [Baseline before surgery, 3 months after surgery]
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
- Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise [Baseline before surgery, 3 months after surgery]
Speech-to-noise ratio, 50% speech understanding
Secondary Outcome Measures
- Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds [Baseline before surgery, 4 weeks and 6 months after surgery]
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
- Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise [Baseline before surgery, 4 weeks and 6 months after surgery]
Speech-to-noise ratio, 50% speech understanding
- Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]
- Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
% correctly perceived words at 50dB, 65dB and 80dB SPL
- Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire [Baseline before surgery, 3 months and 6 months after surgery]
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement.
- Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire [Baseline before surgery, 3 months and 6 months after surgery]
Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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.
- Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire [Baseline before surgery, 3 months and 6 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 Osia 2 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.
- Surgical Information: Soft Tissue Thickness [Baseline before surgery or at surgery]
Measured in mm
- Surgical Information: Surgery Time [At surgery]
Time in minutes between first incision to last suture
- Surgical Information: Bone Polishing/Removal at the Actuator Site [At surgery]
Yes/No
- Surgical Information: BI300 Implant Length [At surgery]
3 mm/4 mm
- Surgical Information: Location of BI300 Implant [At surgery]
Measured in mm between the ear canal and the center of the actuator
- Surgical Information: Type of Anesthesia [At surgery]
General/local
- Surgical Information: Soft Tissue Reduction [At surgery]
Yes/No
- Surgical Information: Surgical Incision Type [At surgery]
Examples: C-shaped/S-shaped/straight
- Surgical Information: Location of the Surgical Incision in Relation to the Actuator [At surgery]
Anterior/posterior
- Surgical Information: Estimated Length of the Surgical Incision [At surgery]
Measured in mm
- Surgical Information: Placement of the Coil [At surgery]
Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
- Usability Information: Magnet Choice [At 4 weeks, 6 weeks, 3 months and 6 months after surgery]
Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet.
- Usability Information: Sound Processor Retention [At 4 weeks, 6 weeks, 3 months and 6 months after surgery]
Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
- Usability Information: Sound Processor Wearing Comfort [At 4 weeks, 6 weeks, 3 months and 6 months after surgery]
Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
- Usability Information: Use of SoftWear Pad [At 6 weeks, 3 months and 6 months after surgery]
Yes/No
- Usability Information: Daily Use of Sound Processor [At 6 weeks, 3 months and 6 months after surgery]
Average hours of daily use
- Usability Information: Daily Streaming Time of Sound Processor [At 6 weeks, 3 months and 6 months after surgery]
Average hours of daily streaming
- Usability Information: Battery Lifetime of Sound Processor [At 6 weeks, 3 months and 6 months after surgery]
Average hours of battery lifetime
- Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz].
- Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].
- Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
Signal-to-noise ratio, 50% speech understanding
- Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
% correctly perceived words at 50dB, 65dB and 80dB SPL
- Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct [Baseline before surgery, 4 weeks, 3 months and 6 months after surgery]
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB sensorineural hearing loss.
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.
-
Adult subjects (18 years or older).
-
Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
-
Candidate is a fluent speaker in the language used to assess speech perception performance.
-
Willing and able to provide written informed consent
Exclusion Criteria:
-
Uncontrolled diabetes as judged by the investigator.
-
Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
-
Insufficient bone quality and quantity to support successful implant placement.
-
Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
-
Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
-
Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
-
Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
-
Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
-
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
-
Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
-
Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sydney Cochlear Implant Centre | Gladesville | Australia | ||
| 2 | The Royal Victorian Eye and Ear Hospital | Melbourne | Australia | ||
| 3 | Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Cochlear
- Statistiska Konsultgruppen
Investigators
- Study Director: Karin Ganlöv, Cochlear
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Cochlear
ClinicalTrials.gov Identifier:
NCT04041700
Other Study ID Numbers:
- CBAS5751
First Posted:
Aug 1, 2019
Last Update Posted:
Aug 18, 2021
Last Verified:
Jul 1, 2021
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
Keywords provided by Cochlear
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 29 participants were recruited in three centres from 16 August 2019 to 24 September 2020. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Period Title: Overall Study | |
| STARTED | 29 |
| COMPLETED | 27 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Overall Participants | 29 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
46.7
(19.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
16
55.2%
|
| Male |
13
44.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
10.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
23
79.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
10.3%
|
| Region of Enrollment (participants) [Number] | |
| Hong Kong |
3
10.3%
|
| Australia |
26
89.7%
|
Outcome Measures
| Title | Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds |
|---|---|
| Description | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) |
| Time Frame | Baseline before surgery, 3 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| Mean (Standard Deviation) [db HL (decibel Hearing Level)] |
-27.3
(8.7)
|
| Title | Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise |
|---|---|
| Description | Speech-to-noise ratio, 50% speech understanding |
| Time Frame | Baseline before surgery, 3 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| Mean (Standard Deviation) [db SNR (decibel Speech in Noise Ratio)] |
-9.10
(7.88)
|
| Title | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds |
|---|---|
| Description | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) |
| Time Frame | Baseline before surgery, 4 weeks and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| At 4 weeks, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At 6 months visit, data was received for 28 participants.The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| 4 weeks |
-25.6
(8.3)
|
| 6 months |
-28.4
(9.6)
|
| Title | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise |
|---|---|
| Description | Speech-to-noise ratio, 50% speech understanding |
| Time Frame | Baseline before surgery, 4 weeks and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| At 4 weeks, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At 6 months visit, data was received for 28 participants.The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| 4 weeks |
-8.76
(8.06)
|
| 6 months |
-8.84
(7.88)
|
| Title | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds |
|---|---|
| Description | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| At the 4 weeks and 3 months visits, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At the 6 months visit, data was received for 28 participants. The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| 0.25 kHz, 4 weeks |
-13.5
(12.0)
|
| 0.5 kHz, 4 weeks |
-23.1
(12.1)
|
| 0.75 kHz, 4 weeks |
-30.2
(10.6)
|
| 1.0 kHz, 4 weeks |
-28.3
(10.1)
|
| 1.5 kHz, 4 weeks |
-30.0
(10.7)
|
| 2.0 kHz, 4 weeks |
-25.7
(9.7)
|
| 3.0 kHz, 4 weeks |
-24.8
(11.6)
|
| 4.0 kHz, 4 weeks |
-25.4
(11.3)
|
| 6.0 kHz, 4 weeks |
-35.0
(11.9)
|
| 8.0 kHz, 4 weeks |
-5.44
(12.9)
|
| 0.25 kHz, 3 months |
-14.8
(11.1)
|
| 0.5 kHz, 3 months |
-24.4
(11.2)
|
| 0.75 kHz, 3 months |
-32.0
(10.8)
|
| 1.0 kHz, 3 months |
-29.1
(10.2)
|
| 1.5 kHz, 3 months |
-30.6
(11.3)
|
| 2.0 kHz, 3 months |
-27.0
(10.9)
|
| 3.0 kHz, 3 months |
-25.2
(11.5)
|
| 4.0 kHz, 3 months |
-28.7
(11.5)
|
| 6.0 kHz, 3 months |
-36.5
(12.1)
|
| 8.0 kHz, 3 months |
-8.59
(13.8)
|
| 0.25 kHz, 6 months |
-14.3
(12.8)
|
| 0.5 kHz, 6 months |
-24.6
(12.2)
|
| 0.75 kHz, 6 months |
-32.0
(11.5)
|
| 1.0 kHz, 6 months |
-31.3
(11.1)
|
| 1.5 kHz, 6 months |
-33.8
(10.9)
|
| 2.0 kHz, 6 months |
-28.4
(12.3)
|
| 3.0 kHz, 6 months |
-26.6
(9.9)
|
| 4.0 kHz, 6 months |
-29.3
(11.3)
|
| 6.0 kHz, 6 months |
-37.3
(12.5)
|
| 8.0 kHz, 6 months |
-7.71
(15.9)
|
| Title | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet |
|---|---|
| Description | % correctly perceived words at 50dB, 65dB and 80dB SPL |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| At the 4 weeks and 3 months visits, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At the 6 months visit, data was received for 28 participants. The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Speech in quiet at 50 dB, 4 weeks |
62.7
(20.7)
|
| Speech in quiet at 65 dB, 4 weeks |
55.1
(29.4)
|
| Speech in quiet at 80 dB, 4 weeks |
23.9
(27.5)
|
| Speech in quiet at 50 dB, 3 months |
63.8
(21.6)
|
| Speech in quiet at 65 dB, 3 months |
55.5
(29.3)
|
| Speech in quiet at 80 dB, 3 months |
23.7
(27.7)
|
| Speech in quiet at 50 dB, 6 months |
62.3
(22.1)
|
| Speech in quiet at 65 dB, 6 months |
54.0
(29.8)
|
| Speech in quiet at 80 dB, 6 months |
24.3
(28.0)
|
| Title | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire |
|---|---|
| Description | Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement. |
| Time Frame | Baseline before surgery, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit. One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| APHAB - Ease of communication, 3 months |
28.1
(30.7)
|
| APHAB - Background Noise, 3 months |
27.6
(26.9)
|
| APHAB - Reverberation, 3 months |
20.3
(24.3)
|
| APHAB - Aversiveness, 3 months |
-5.2
(34.9)
|
| APHAB - Global, 3 months |
25.4
(25.0)
|
| APHAB - Ease of communication, 6 months |
27.4
(31.4)
|
| APHAB - Background Noise, 6 months |
28.7
(28.1)
|
| APHAB - Reverberation, 6 months |
21.7
(26.4)
|
| APHAB - Aversiveness, 6 months |
-0.212
(33.0)
|
| APHAB - Global, 6 months |
25.9
(26.2)
|
| Title | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire |
|---|---|
| Description | Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit. One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| SSQ12 Total score, 3 months |
2.88
(1.56)
|
| SSQ12 Speech score, 3 months |
3.12
(1.78)
|
| SSQ12 Spatial score, 3 months |
2.92
(2.07)
|
| SSQ12 Quality score, 3 months |
2.55
(1.78)
|
| SSQ12 Total score, 6 months |
2.50
(1.66)
|
| SSQ12 Speech score, 6 months |
2.68
(1.89)
|
| SSQ12 Spatial score, 6 months |
2.30
(2.42)
|
| SSQ12 Quality score, 6 months |
2.41
(1.81)
|
| Title | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire |
|---|---|
| Description | Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 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. |
| Time Frame | Baseline before surgery, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit. One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| Comprehensive Health State, 3 months |
0.097
(0.167)
|
| Vision attribute, 3 months |
0.002
(0.017)
|
| Hearing attribute, 3 months |
0.113
(0.288)
|
| Speech attribute, 3 months |
0.006
(0.076)
|
| Ambulation attribute, 3 months |
-0.006
(0.033)
|
| Dexterity attribute, 3 months |
0.031
(0.117)
|
| Emotion attribute, 3 months |
0.033
(0.071)
|
| Cognition attribute, 3 months |
0.011
(0.040)
|
| Pain attribute (HUI3), 3 months |
0.009
(0.061)
|
| Comprehensive Health State, 6 months |
0.091
(0.165)
|
| Vision attribute, 6 months |
-0.004
(0.013)
|
| Hearing attribute, 6 months |
0.129
(0.318)
|
| Speech attribute, 6 months |
0.000
(0.106)
|
| Ambulation attribute, 6 months |
0.013
(0.045)
|
| Dexterity attribute, 6 months |
0.026
(0.120)
|
| Emotion attribute, 6 months |
0.020
(0.063)
|
| Cognition attribute, 6 months |
0.001
(0.064)
|
| Pain attribute (HUI3), 6 months |
0.011
(0.123)
|
| Title | Surgical Information: Soft Tissue Thickness |
|---|---|
| Description | Measured in mm |
| Time Frame | Baseline before surgery or at surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| Mean (Standard Deviation) [mm] |
6.62
(1.29)
|
| Title | Surgical Information: Surgery Time |
|---|---|
| Description | Time in minutes between first incision to last suture |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Surgery time was not measured for one of the participants. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Mean (Standard Deviation) [min] |
52.8
(13.3)
|
| Title | Surgical Information: Bone Polishing/Removal at the Actuator Site |
|---|---|
| Description | Yes/No |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| Yes |
12
41.4%
|
| No |
17
58.6%
|
| Title | Surgical Information: BI300 Implant Length |
|---|---|
| Description | 3 mm/4 mm |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| 3 mm |
0
0%
|
| 4 mm |
29
100%
|
| Title | Surgical Information: Location of BI300 Implant |
|---|---|
| Description | Measured in mm between the ear canal and the center of the actuator |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data only gathered for 26 participants. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 26 |
| Mean (Standard Deviation) [mm] |
52.9
(7.3)
|
| Title | Surgical Information: Type of Anesthesia |
|---|---|
| Description | General/local |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| General |
29
100%
|
| Local |
0
0%
|
| Title | Surgical Information: Soft Tissue Reduction |
|---|---|
| Description | Yes/No |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| Yes |
0
0%
|
| No |
29
100%
|
| Title | Surgical Information: Surgical Incision Type |
|---|---|
| Description | Examples: C-shaped/S-shaped/straight |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| C-shaped |
12
41.4%
|
| S-shaped |
12
41.4%
|
| Other |
5
17.2%
|
| Straight |
0
0%
|
| Title | Surgical Information: Location of the Surgical Incision in Relation to the Actuator |
|---|---|
| Description | Anterior/posterior |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| Anterior |
26
89.7%
|
| Posterior |
3
10.3%
|
| Title | Surgical Information: Estimated Length of the Surgical Incision |
|---|---|
| Description | Measured in mm |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| Mean (Standard Deviation) [mm] |
71.4
(23.1)
|
| Title | Surgical Information: Placement of the Coil |
|---|---|
| Description | Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle) |
| Time Frame | At surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 29 |
| Periosteal pocket (under periosteal) |
24
82.8%
|
| on top of periosteum |
3
10.3%
|
| on top of muscle |
2
6.9%
|
| Title | Usability Information: Magnet Choice |
|---|---|
| Description | Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet. |
| Time Frame | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| For some participants the data are not available at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Magnet strength 2, 4 weeks |
1
3.4%
|
| Magnet strength 3, 4 weeks |
11
37.9%
|
| Magnet strength 4, 4 weeks |
16
55.2%
|
| Magnet strength 2, 6 weeks |
1
3.4%
|
| Magnet strength 3, 6 weeks |
13
44.8%
|
| Magnet strength 4, 6 weeks |
13
44.8%
|
| Magnet strength 2, 3 months |
4
13.8%
|
| Magnet strength 3, 3 months |
10
34.5%
|
| Magnet strength 4, 3 months |
14
48.3%
|
| Magnet strength 2, 6 months |
4
13.8%
|
| Magnet strength 3, 6 months |
12
41.4%
|
| Magnet strength 4, 6 months |
11
37.9%
|
| Title | Usability Information: Sound Processor Retention |
|---|---|
| Description | Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention |
| Time Frame | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform the test at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| Overall Retention, 4 weeks |
72.1
(22.8)
|
| Overall Retention, 6 weeks |
86.9
(13.9)
|
| Overall Retention, 3 months |
80.4
(17.1)
|
| Overall Retention, 6 months |
71.4
(26.7)
|
| Title | Usability Information: Sound Processor Wearing Comfort |
|---|---|
| Description | Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort |
| Time Frame | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform the test at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 27 |
| Overall Comfort, 4 weeks |
81.7
(14.1)
|
| Overall Comfort, 6 weeks |
87.1
(16.8)
|
| Overall Comfort, 3 months |
83.5
(16.4)
|
| Overall Comfort, 6 months |
81.4
(20.0)
|
| Title | Usability Information: Use of SoftWear Pad |
|---|---|
| Description | Yes/No |
| Time Frame | At 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| For some participants the data are not available at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Yes, 6 weeks |
3
10.3%
|
| No, 6 weeks |
24
82.8%
|
| Yes, 3 months |
4
13.8%
|
| No, 3 months |
24
82.8%
|
| Yes, 6 months |
2
6.9%
|
| No, 6 months |
25
86.2%
|
| Title | Usability Information: Daily Use of Sound Processor |
|---|---|
| Description | Average hours of daily use |
| Time Frame | At 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| For some participants the data are not available at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Daily use, 6 weeks |
10.3
(4.4)
|
| Daily use, 3 months |
9.57
(4.19)
|
| Daily use, 6 months |
8.63
(4.67)
|
| Title | Usability Information: Daily Streaming Time of Sound Processor |
|---|---|
| Description | Average hours of daily streaming |
| Time Frame | At 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| For some participants the data are not available at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Streaming, 6 weeks |
0.407
(0.931)
|
| Streaming, 3 months |
0.536
(0.962)
|
| Streaming, 6 months |
0.444
(0.698)
|
| Title | Usability Information: Battery Lifetime of Sound Processor |
|---|---|
| Description | Average hours of battery lifetime |
| Time Frame | At 6 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| For some participants the data are not available at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| 6 weeks |
27.3
(15.0)
|
| 3 months |
27.4
(11.2)
|
| 6 months |
24.3
(12.4)
|
| Title | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds |
|---|---|
| Description | Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz]. |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform the test at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| PTA4, 4 weeks |
0.046
(7.134)
|
| PTA4, 3 months |
-1.62
(6.41)
|
| PTA4, 6 months |
-2.54
(8.32)
|
| Title | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds |
|---|---|
| Description | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform the test at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| 0.25 kHz, 4 weeks |
4.44
(13.18)
|
| 0.5 kHz, 4 weeks |
4.44
(10.13)
|
| 0.75 kHz, 4 weeks |
-0.741
(6.893)
|
| 1.0 kHz, 4 weeks |
1.85
(7.61)
|
| 1.5 kHz, 4 weeks |
0.185
(8.376)
|
| 2.0 kHz, 4 weeks |
-2.22
(8.70)
|
| 3.0 kHz, 4 weeks |
-1.48
(10.27)
|
| 4.0 kHz, 4 weeks |
-3.89
(11.21)
|
| 6.0 kHz, 4 weeks |
-11.9
(10.9)
|
| 8.0 kHz, 4 weeks |
4.78
(16.49)
|
| 0.25 kHz, 3 months |
3.15
(10.57)
|
| 0.5 kHz, 3 months |
3.15
(9.11)
|
| 0.75 kHz, 3 months |
-2.59
(6.70)
|
| 1.0 kHz, 3 months |
1.11
(6.55)
|
| 1.5 kHz, 3 months |
-0,370
(7,836)
|
| 2.0 kHz, 3 months |
-3.52
(8.64)
|
| 3.0 kHz, 3 months |
-1.85
(10.48)
|
| 4.0 kHz, 3 months |
-7.22
(10.41)
|
| 6.0 kHz, 3 months |
-13.3
(10.3)
|
| 8.0 kHz, 3 months |
1.63
(15.20)
|
| 0.25 kHz, 6 months |
3.93
(13.77)
|
| 0.5 kHz, 6 months |
2.86
(9.95)
|
| 0.75 kHz, 6 months |
-2.68
(8.76)
|
| 1.0 kHz, 6 months |
-1.07
(7.98)
|
| 1.5 kHz, 6 months |
-3.39
(7.34)
|
| 2.0 kHz, 6 months |
-4.64
(10.97)
|
| 3.0 kHz, 6 months |
-3.04
(12.35)
|
| 4.0 kHz, 6 months |
-7.32
(11.26)
|
| 6.0 kHz, 6 months |
-13.9
(13.6)
|
| 8.0 kHz, 6 months |
2.86
(17.87)
|
| Title | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise |
|---|---|
| Description | Signal-to-noise ratio, 50% speech understanding |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform the test at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| 4 weeks |
-0.870
(1.366)
|
| 3 months |
-1.21
(1.42)
|
| 6 months |
-0.846
(1.587)
|
| Title | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet |
|---|---|
| Description | % correctly perceived words at 50dB, 65dB and 80dB SPL |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform all tests at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| Speech in quiet at 50 dB, 4 weeks |
12.2
(18.3)
|
| Speech in quiet at 65 dB, 4 weeks |
9.77
(14.76)
|
| Speech in quiet at 80 dB, 4 weeks |
2.88
(10.21)
|
| Speech in quiet at 50 dB, 3 months |
13.2
(18.8)
|
| Speech in quiet at 65 dB, 3 months |
10.1
(16.0)
|
| Speech in quiet at 80 dB, 3 months |
2.66
(10.13)
|
| Speech in quiet at 50 dB, 6 months |
10.7
(18.3)
|
| Speech in quiet at 65 dB, 6 months |
8.84
(15.22)
|
| Speech in quiet at 80 dB, 6 months |
4.00
(8.26)
|
| Title | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct |
|---|---|
| Description | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) |
| Time Frame | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not perform the test at all visits. |
| Arm/Group Title | Osia 2 System |
|---|---|
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure Participants | 28 |
| BC Direct 250 Hz, baseline |
13.2
(10.2)
|
| BC Direct 500 Hz, baseline |
24.7
(11.3)
|
| BC Direct 750 Hz, baseline |
20.7
(12.4)
|
| BC Direct 1000 Hz, baseline |
20.0
(13.5)
|
| BC Direct 1500 Hz, baseline |
19.1
(14.6)
|
| BC Direct 2000 Hz, baseline |
31.2
(15.3)
|
| BC Direct 3000 Hz, baseline |
36.8
(18.7)
|
| BC Direct 4000 Hz, baseline |
43.5
(17.6)
|
| BC Direct 6000 Hz, baseline |
46.1
(17.6)
|
| BC Direct 250 Hz, 4 weeks |
5.18
(12.87)
|
| BC Direct 500 Hz, 4 weeks |
14.5
(8.7)
|
| BC Direct 750 Hz, 4 weeks |
5.71
(11.20)
|
| BC Direct 1000 Hz, 4 weeks |
9.46
(11.33)
|
| BC Direct 1500 Hz, 4 weeks |
7.50
(13.23)
|
| BC Direct 2000 Hz, 4 weeks |
12.0
(14.2)
|
| BC Direct 3000 Hz, 4 weeks |
13.9
(15.4)
|
| BC Direct 4000 Hz, 4 weeks |
23.8
(17.1)
|
| BC Direct 6000 Hz, 4 weeks |
22.0
(18.7)
|
| BC Direct 250 Hz, 3 months |
4.00
(11.21)
|
| BC Direct 500 Hz, 3 months |
13.0
(9.8)
|
| BC Direct 750 Hz, 3 months |
4.33
(12.08)
|
| BC Direct 1000 Hz, 3 months |
9.67
(13.29)
|
| BC Direct 1500 Hz, 3 months |
6.67
(15.43)
|
| BC Direct 2000 Hz, 3 months |
14.0
(15.9)
|
| BC Direct 3000 Hz, 3 months |
13.3
(18.5)
|
| BC Direct 4000 Hz, 3 months |
24.3
(17.4)
|
| BC Direct 6000 Hz, 3 months |
27.0
(18.5)
|
| BC Direct 250 Hz, 6 months |
8.10
(13.83)
|
| BC Direct 500 Hz, 6 months |
15.0
(8.5)
|
| BC Direct 750 Hz, 6 months |
6.90
(12.60)
|
| BC Direct 1000 Hz, 6 months |
10.7
(11.3)
|
| BC Direct 1500 Hz, 6 months |
5.95
(13.84)
|
| BC Direct 2000 Hz, 6 months |
14.3
(13.7)
|
| BC Direct 3000 Hz, 6 months |
13.6
(17.0)
|
| BC Direct 4000 Hz, 6 months |
25.7
(16.9)
|
| BC Direct 6000 Hz, 6 months |
25.0
(18.8)
|
Adverse Events
| Time Frame | 6 months | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events are presented by the CTCAE term. | |
| Arm/Group Title | Osia 2 System | |
| Arm/Group Description | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. | |
All Cause Mortality |
||
| Osia 2 System | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | |
Serious Adverse Events |
||
| Osia 2 System | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/29 (10.3%) | |
| Cardiac disorders | ||
| Preoperative Bradycardia | 1/29 (3.4%) | 29 |
| Infections and infestations | ||
| Gastroenteritis | 1/29 (3.4%) | 29 |
| Infected Skin/ Wound With Subcutaneous Collection | 1/29 (3.4%) | 29 |
| Infected Wound/Possible Flap Compromise | 1/29 (3.4%) | 29 |
Other (Not Including Serious) Adverse Events |
||
| Osia 2 System | ||
| Affected / at Risk (%) | # Events | |
| Total | 21/29 (72.4%) | |
| Ear and labyrinth disorders | ||
| Ear and labyrinth disorders - Other | 5/29 (17.2%) | 29 |
| General disorders | ||
| General disorders and administration site conditions - Other | 5/29 (17.2%) | 29 |
| Infections and infestations | ||
| Wound infection | 4/29 (13.8%) | 29 |
| Injury, poisoning and procedural complications | ||
| Wound complication | 6/29 (20.7%) | 29 |
| Musculoskeletal and connective tissue disorders | ||
| Neck pain | 2/29 (6.9%) | 29 |
| Psychiatric disorders | ||
| Psychiatric Disorders - Other | 2/29 (6.9%) | 29 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The institutions agree that no publication of the study results may be made until publication of the results of the multi-centre study or 2 years after study completion, whichever is the sooner.
Results Point of Contact
| Name/Title | Johan Blechert |
|---|---|
| Organization | Cochlear |
| Phone | +46766498632 |
| jblechert@cochlear.com |
Responsible Party:
Cochlear
ClinicalTrials.gov Identifier:
NCT04041700
Other Study ID Numbers:
- CBAS5751
First Posted:
Aug 1, 2019
Last Update Posted:
Aug 18, 2021
Last Verified:
Jul 1, 2021