Trial Outcomes & Findings for Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System (NCT NCT04041700)
NCT ID: NCT04041700
Last Updated: 2021-08-18
Results Overview
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Baseline before surgery, 3 months after surgery
Results posted on
2021-08-18
Participant Flow
29 participants were recruited in three centres from 16 August 2019 to 24 September 2020.
Participant milestones
| Measure |
Osia 2 System
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.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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27
|
|
Overall Study
NOT COMPLETED
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2
|
Reasons for withdrawal
| Measure |
Osia 2 System
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.
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|---|---|
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Overall Study
Pregnancy
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1
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Overall Study
Unable to visit the site due to the Covid-19 travel restrictions
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1
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Baseline Characteristics
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Baseline characteristics by cohort
| Measure |
Osia 2 System
n=29 Participants
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.
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|---|---|
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Age, Continuous
|
46.7 years
STANDARD_DEVIATION 19.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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3 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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23 Participants
n=5 Participants
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|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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|
Region of Enrollment
Hong Kong
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3 participants
n=5 Participants
|
|
Region of Enrollment
Australia
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26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline before surgery, 3 months after surgeryPopulation: 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.
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
|
-27.3 db HL (decibel Hearing Level)
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: Baseline before surgery, 3 months after surgeryPopulation: 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.
Speech-to-noise ratio, 50% speech understanding
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
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
|
-9.10 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 7.88
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks and 6 months after surgeryPopulation: 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.
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
4 weeks
|
-25.6 db HL (decibel Hearing Level)
Standard Deviation 8.3
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|
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
6 months
|
-28.4 db HL (decibel Hearing Level)
Standard Deviation 9.6
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SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks and 6 months after surgeryPopulation: 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.
Speech-to-noise ratio, 50% speech understanding
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
4 weeks
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-8.76 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 8.06
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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
6 months
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-8.84 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 7.88
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SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: 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.
Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
0.25 kHz, 4 weeks
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-13.5 db HL (decibel Hearing Level)
Standard Deviation 12.0
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|
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
0.5 kHz, 4 weeks
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-23.1 db HL (decibel Hearing Level)
Standard Deviation 12.1
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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
0.75 kHz, 4 weeks
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-30.2 db HL (decibel Hearing Level)
Standard Deviation 10.6
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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
1.0 kHz, 4 weeks
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-28.3 db HL (decibel Hearing Level)
Standard Deviation 10.1
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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
1.5 kHz, 4 weeks
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-30.0 db HL (decibel Hearing Level)
Standard Deviation 10.7
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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
2.0 kHz, 4 weeks
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-25.7 db HL (decibel Hearing Level)
Standard Deviation 9.7
|
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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
3.0 kHz, 4 weeks
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-24.8 db HL (decibel Hearing Level)
Standard Deviation 11.6
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|
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
4.0 kHz, 4 weeks
|
-25.4 db HL (decibel Hearing Level)
Standard Deviation 11.3
|
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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
6.0 kHz, 4 weeks
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-35.0 db HL (decibel Hearing Level)
Standard Deviation 11.9
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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
8.0 kHz, 4 weeks
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-5.44 db HL (decibel Hearing Level)
Standard Deviation 12.9
|
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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
0.25 kHz, 3 months
|
-14.8 db HL (decibel Hearing Level)
Standard Deviation 11.1
|
|
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
0.5 kHz, 3 months
|
-24.4 db HL (decibel Hearing Level)
Standard Deviation 11.2
|
|
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
0.75 kHz, 3 months
|
-32.0 db HL (decibel Hearing Level)
Standard Deviation 10.8
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|
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
1.0 kHz, 3 months
|
-29.1 db HL (decibel Hearing Level)
Standard Deviation 10.2
|
|
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
1.5 kHz, 3 months
|
-30.6 db HL (decibel Hearing Level)
Standard Deviation 11.3
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|
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
2.0 kHz, 3 months
|
-27.0 db HL (decibel Hearing Level)
Standard Deviation 10.9
|
|
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
3.0 kHz, 3 months
|
-25.2 db HL (decibel Hearing Level)
Standard Deviation 11.5
|
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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
4.0 kHz, 3 months
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-28.7 db HL (decibel Hearing Level)
Standard Deviation 11.5
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|
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
6.0 kHz, 3 months
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-36.5 db HL (decibel Hearing Level)
Standard Deviation 12.1
|
|
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
8.0 kHz, 3 months
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-8.59 db HL (decibel Hearing Level)
Standard Deviation 13.8
|
|
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
0.25 kHz, 6 months
|
-14.3 db HL (decibel Hearing Level)
Standard Deviation 12.8
|
|
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
0.5 kHz, 6 months
|
-24.6 db HL (decibel Hearing Level)
Standard Deviation 12.2
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|
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
0.75 kHz, 6 months
|
-32.0 db HL (decibel Hearing Level)
Standard Deviation 11.5
|
|
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
1.0 kHz, 6 months
|
-31.3 db HL (decibel Hearing Level)
Standard Deviation 11.1
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|
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
1.5 kHz, 6 months
|
-33.8 db HL (decibel Hearing Level)
Standard Deviation 10.9
|
|
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
2.0 kHz, 6 months
|
-28.4 db HL (decibel Hearing Level)
Standard Deviation 12.3
|
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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
3.0 kHz, 6 months
|
-26.6 db HL (decibel Hearing Level)
Standard Deviation 9.9
|
|
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
4.0 kHz, 6 months
|
-29.3 db HL (decibel Hearing Level)
Standard Deviation 11.3
|
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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
6.0 kHz, 6 months
|
-37.3 db HL (decibel Hearing Level)
Standard Deviation 12.5
|
|
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
8.0 kHz, 6 months
|
-7.71 db HL (decibel Hearing Level)
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: 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.
% correctly perceived words at 50dB, 65dB and 80dB SPL
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
Speech in quiet at 50 dB, 4 weeks
|
62.7 Percentage of correct words
Standard Deviation 20.7
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|
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
Speech in quiet at 65 dB, 4 weeks
|
55.1 Percentage of correct words
Standard Deviation 29.4
|
|
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
Speech in quiet at 80 dB, 4 weeks
|
23.9 Percentage of correct words
Standard Deviation 27.5
|
|
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
Speech in quiet at 50 dB, 3 months
|
63.8 Percentage of correct words
Standard Deviation 21.6
|
|
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
Speech in quiet at 65 dB, 3 months
|
55.5 Percentage of correct words
Standard Deviation 29.3
|
|
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
Speech in quiet at 80 dB, 3 months
|
23.7 Percentage of correct words
Standard Deviation 27.7
|
|
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
Speech in quiet at 50 dB, 6 months
|
62.3 Percentage of correct words
Standard Deviation 22.1
|
|
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
Speech in quiet at 65 dB, 6 months
|
54.0 Percentage of correct words
Standard Deviation 29.8
|
|
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
Speech in quiet at 80 dB, 6 months
|
24.3 Percentage of correct words
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: Baseline before surgery, 3 months and 6 months after surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
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
APHAB - Ease of communication, 3 months
|
28.1 units on a scale
Standard Deviation 30.7
|
|
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
APHAB - Background Noise, 3 months
|
27.6 units on a scale
Standard Deviation 26.9
|
|
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
APHAB - Reverberation, 3 months
|
20.3 units on a scale
Standard Deviation 24.3
|
|
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
APHAB - Aversiveness, 3 months
|
-5.2 units on a scale
Standard Deviation 34.9
|
|
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
APHAB - Global, 3 months
|
25.4 units on a scale
Standard Deviation 25.0
|
|
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
APHAB - Ease of communication, 6 months
|
27.4 units on a scale
Standard Deviation 31.4
|
|
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
APHAB - Background Noise, 6 months
|
28.7 units on a scale
Standard Deviation 28.1
|
|
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
APHAB - Reverberation, 6 months
|
21.7 units on a scale
Standard Deviation 26.4
|
|
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
APHAB - Aversiveness, 6 months
|
-0.212 units on a scale
Standard Deviation 33.0
|
|
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
APHAB - Global, 6 months
|
25.9 units on a scale
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: Baseline before surgery, 3 months and 6 months after surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
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
SSQ12 Total score, 3 months
|
2.88 Score on a scale
Standard Deviation 1.56
|
|
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
SSQ12 Speech score, 3 months
|
3.12 Score on a scale
Standard Deviation 1.78
|
|
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
SSQ12 Spatial score, 3 months
|
2.92 Score on a scale
Standard Deviation 2.07
|
|
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
SSQ12 Quality score, 3 months
|
2.55 Score on a scale
Standard Deviation 1.78
|
|
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
SSQ12 Total score, 6 months
|
2.50 Score on a scale
Standard Deviation 1.66
|
|
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
SSQ12 Speech score, 6 months
|
2.68 Score on a scale
Standard Deviation 1.89
|
|
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
SSQ12 Spatial score, 6 months
|
2.30 Score on a scale
Standard Deviation 2.42
|
|
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
SSQ12 Quality score, 6 months
|
2.41 Score on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Baseline before surgery, 3 months and 6 months after surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
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
Comprehensive Health State, 3 months
|
0.097 score on a scale
Standard Deviation 0.167
|
|
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
Vision attribute, 3 months
|
0.002 score on a scale
Standard Deviation 0.017
|
|
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
Hearing attribute, 3 months
|
0.113 score on a scale
Standard Deviation 0.288
|
|
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
Speech attribute, 3 months
|
0.006 score on a scale
Standard Deviation 0.076
|
|
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
Ambulation attribute, 3 months
|
-0.006 score on a scale
Standard Deviation 0.033
|
|
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
Dexterity attribute, 3 months
|
0.031 score on a scale
Standard Deviation 0.117
|
|
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
Emotion attribute, 3 months
|
0.033 score on a scale
Standard Deviation 0.071
|
|
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
Cognition attribute, 3 months
|
0.011 score on a scale
Standard Deviation 0.040
|
|
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
Pain attribute (HUI3), 3 months
|
0.009 score on a scale
Standard Deviation 0.061
|
|
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
Comprehensive Health State, 6 months
|
0.091 score on a scale
Standard Deviation 0.165
|
|
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
Vision attribute, 6 months
|
-0.004 score on a scale
Standard Deviation 0.013
|
|
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
Hearing attribute, 6 months
|
0.129 score on a scale
Standard Deviation 0.318
|
|
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
Speech attribute, 6 months
|
0.000 score on a scale
Standard Deviation 0.106
|
|
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
Ambulation attribute, 6 months
|
0.013 score on a scale
Standard Deviation 0.045
|
|
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
Dexterity attribute, 6 months
|
0.026 score on a scale
Standard Deviation 0.120
|
|
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
Emotion attribute, 6 months
|
0.020 score on a scale
Standard Deviation 0.063
|
|
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
Cognition attribute, 6 months
|
0.001 score on a scale
Standard Deviation 0.064
|
|
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
Pain attribute (HUI3), 6 months
|
0.011 score on a scale
Standard Deviation 0.123
|
SECONDARY outcome
Timeframe: Baseline before surgery or at surgeryMeasured in mm
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Soft Tissue Thickness
|
6.62 mm
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: At surgeryPopulation: Surgery time was not measured for one of the participants.
Time in minutes between first incision to last suture
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
Surgical Information: Surgery Time
|
52.8 min
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: At surgeryYes/No
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Bone Polishing/Removal at the Actuator Site
Yes
|
12 Participants
|
|
Surgical Information: Bone Polishing/Removal at the Actuator Site
No
|
17 Participants
|
SECONDARY outcome
Timeframe: At surgery3 mm/4 mm
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: BI300 Implant Length
3 mm
|
0 Participants
|
|
Surgical Information: BI300 Implant Length
4 mm
|
29 Participants
|
SECONDARY outcome
Timeframe: At surgeryPopulation: Data only gathered for 26 participants.
Measured in mm between the ear canal and the center of the actuator
Outcome measures
| Measure |
Osia 2 System
n=26 Participants
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.
|
|---|---|
|
Surgical Information: Location of BI300 Implant
|
52.9 mm
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: At surgeryGeneral/local
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Type of Anesthesia
General
|
29 Participants
|
|
Surgical Information: Type of Anesthesia
Local
|
0 Participants
|
SECONDARY outcome
Timeframe: At surgeryYes/No
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Soft Tissue Reduction
Yes
|
0 Participants
|
|
Surgical Information: Soft Tissue Reduction
No
|
29 Participants
|
SECONDARY outcome
Timeframe: At surgeryExamples: C-shaped/S-shaped/straight
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Surgical Incision Type
C-shaped
|
12 Participants
|
|
Surgical Information: Surgical Incision Type
S-shaped
|
12 Participants
|
|
Surgical Information: Surgical Incision Type
Other
|
5 Participants
|
|
Surgical Information: Surgical Incision Type
Straight
|
0 Participants
|
SECONDARY outcome
Timeframe: At surgeryAnterior/posterior
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Posterior
|
3 Participants
|
|
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Anterior
|
26 Participants
|
SECONDARY outcome
Timeframe: At surgeryMeasured in mm
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Estimated Length of the Surgical Incision
|
71.4 mm
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: At surgeryPeriosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
Outcome measures
| Measure |
Osia 2 System
n=29 Participants
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.
|
|---|---|
|
Surgical Information: Placement of the Coil
Periosteal pocket (under periosteal)
|
24 Participants
|
|
Surgical Information: Placement of the Coil
on top of periosteum
|
3 Participants
|
|
Surgical Information: Placement of the Coil
on top of muscle
|
2 Participants
|
SECONDARY outcome
Timeframe: At 4 weeks, 6 weeks, 3 months and 6 months after surgeryPopulation: For some participants the data are not available at all visits.
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.
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
Usability Information: Magnet Choice
Magnet strength 2, 4 weeks
|
1 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 3, 4 weeks
|
11 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 4, 4 weeks
|
16 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 2, 6 weeks
|
1 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 3, 6 weeks
|
13 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 4, 6 weeks
|
13 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 2, 3 months
|
4 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 3, 3 months
|
10 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 4, 3 months
|
14 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 2, 6 months
|
4 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 3, 6 months
|
12 Participants
|
|
Usability Information: Magnet Choice
Magnet strength 4, 6 months
|
11 Participants
|
SECONDARY outcome
Timeframe: At 4 weeks, 6 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform the test at all visits.
Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
Usability Information: Sound Processor Retention
Overall Retention, 4 weeks
|
72.1 units on a scale
Standard Deviation 22.8
|
|
Usability Information: Sound Processor Retention
Overall Retention, 6 weeks
|
86.9 units on a scale
Standard Deviation 13.9
|
|
Usability Information: Sound Processor Retention
Overall Retention, 3 months
|
80.4 units on a scale
Standard Deviation 17.1
|
|
Usability Information: Sound Processor Retention
Overall Retention, 6 months
|
71.4 units on a scale
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: At 4 weeks, 6 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform the test at all visits.
Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
Outcome measures
| Measure |
Osia 2 System
n=27 Participants
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.
|
|---|---|
|
Usability Information: Sound Processor Wearing Comfort
Overall Comfort, 4 weeks
|
81.7 units on a scale
Standard Deviation 14.1
|
|
Usability Information: Sound Processor Wearing Comfort
Overall Comfort, 6 weeks
|
87.1 units on a scale
Standard Deviation 16.8
|
|
Usability Information: Sound Processor Wearing Comfort
Overall Comfort, 3 months
|
83.5 units on a scale
Standard Deviation 16.4
|
|
Usability Information: Sound Processor Wearing Comfort
Overall Comfort, 6 months
|
81.4 units on a scale
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: At 6 weeks, 3 months and 6 months after surgeryPopulation: For some participants the data are not available at all visits.
Yes/No
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
Usability Information: Use of SoftWear Pad
Yes, 6 weeks
|
3 Participants
|
|
Usability Information: Use of SoftWear Pad
No, 6 weeks
|
24 Participants
|
|
Usability Information: Use of SoftWear Pad
Yes, 3 months
|
4 Participants
|
|
Usability Information: Use of SoftWear Pad
No, 3 months
|
24 Participants
|
|
Usability Information: Use of SoftWear Pad
Yes, 6 months
|
2 Participants
|
|
Usability Information: Use of SoftWear Pad
No, 6 months
|
25 Participants
|
SECONDARY outcome
Timeframe: At 6 weeks, 3 months and 6 months after surgeryPopulation: For some participants the data are not available at all visits.
Average hours of daily use
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
Usability Information: Daily Use of Sound Processor
Daily use, 6 weeks
|
10.3 hours/day
Standard Deviation 4.4
|
|
Usability Information: Daily Use of Sound Processor
Daily use, 3 months
|
9.57 hours/day
Standard Deviation 4.19
|
|
Usability Information: Daily Use of Sound Processor
Daily use, 6 months
|
8.63 hours/day
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: At 6 weeks, 3 months and 6 months after surgeryPopulation: For some participants the data are not available at all visits.
Average hours of daily streaming
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
Usability Information: Daily Streaming Time of Sound Processor
Streaming, 6 weeks
|
0.407 hours/day
Standard Deviation 0.931
|
|
Usability Information: Daily Streaming Time of Sound Processor
Streaming, 3 months
|
0.536 hours/day
Standard Deviation 0.962
|
|
Usability Information: Daily Streaming Time of Sound Processor
Streaming, 6 months
|
0.444 hours/day
Standard Deviation 0.698
|
SECONDARY outcome
Timeframe: At 6 weeks, 3 months and 6 months after surgeryPopulation: For some participants the data are not available at all visits.
Average hours of battery lifetime
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
Usability Information: Battery Lifetime of Sound Processor
6 weeks
|
27.3 hours
Standard Deviation 15.0
|
|
Usability Information: Battery Lifetime of Sound Processor
3 months
|
27.4 hours
Standard Deviation 11.2
|
|
Usability Information: Battery Lifetime of Sound Processor
6 months
|
24.3 hours
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform the test at all visits.
Free-field \[Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz\].
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
PTA4, 4 weeks
|
0.046 db HL (decibel Hearing Level)
Standard Deviation 7.134
|
|
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
PTA4, 3 months
|
-1.62 db HL (decibel Hearing Level)
Standard Deviation 6.41
|
|
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
PTA4, 6 months
|
-2.54 db HL (decibel Hearing Level)
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform the test at all visits.
Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\].
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
0.25 kHz, 4 weeks
|
4.44 db HL (decibel Hearing Level)
Standard Deviation 13.18
|
|
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
0.5 kHz, 4 weeks
|
4.44 db HL (decibel Hearing Level)
Standard Deviation 10.13
|
|
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
0.75 kHz, 4 weeks
|
-0.741 db HL (decibel Hearing Level)
Standard Deviation 6.893
|
|
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
1.0 kHz, 4 weeks
|
1.85 db HL (decibel Hearing Level)
Standard Deviation 7.61
|
|
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
1.5 kHz, 4 weeks
|
0.185 db HL (decibel Hearing Level)
Standard Deviation 8.376
|
|
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
2.0 kHz, 4 weeks
|
-2.22 db HL (decibel Hearing Level)
Standard Deviation 8.70
|
|
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
3.0 kHz, 4 weeks
|
-1.48 db HL (decibel Hearing Level)
Standard Deviation 10.27
|
|
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
4.0 kHz, 4 weeks
|
-3.89 db HL (decibel Hearing Level)
Standard Deviation 11.21
|
|
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
6.0 kHz, 4 weeks
|
-11.9 db HL (decibel Hearing Level)
Standard Deviation 10.9
|
|
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
8.0 kHz, 4 weeks
|
4.78 db HL (decibel Hearing Level)
Standard Deviation 16.49
|
|
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
0.25 kHz, 3 months
|
3.15 db HL (decibel Hearing Level)
Standard Deviation 10.57
|
|
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
0.5 kHz, 3 months
|
3.15 db HL (decibel Hearing Level)
Standard Deviation 9.11
|
|
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
0.75 kHz, 3 months
|
-2.59 db HL (decibel Hearing Level)
Standard Deviation 6.70
|
|
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
1.0 kHz, 3 months
|
1.11 db HL (decibel Hearing Level)
Standard Deviation 6.55
|
|
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
1.5 kHz, 3 months
|
-0,370 db HL (decibel Hearing Level)
Standard Deviation 7,836
|
|
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
2.0 kHz, 3 months
|
-3.52 db HL (decibel Hearing Level)
Standard Deviation 8.64
|
|
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
3.0 kHz, 3 months
|
-1.85 db HL (decibel Hearing Level)
Standard Deviation 10.48
|
|
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
4.0 kHz, 3 months
|
-7.22 db HL (decibel Hearing Level)
Standard Deviation 10.41
|
|
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
6.0 kHz, 3 months
|
-13.3 db HL (decibel Hearing Level)
Standard Deviation 10.3
|
|
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
8.0 kHz, 3 months
|
1.63 db HL (decibel Hearing Level)
Standard Deviation 15.20
|
|
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
0.25 kHz, 6 months
|
3.93 db HL (decibel Hearing Level)
Standard Deviation 13.77
|
|
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
0.5 kHz, 6 months
|
2.86 db HL (decibel Hearing Level)
Standard Deviation 9.95
|
|
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
0.75 kHz, 6 months
|
-2.68 db HL (decibel Hearing Level)
Standard Deviation 8.76
|
|
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
1.0 kHz, 6 months
|
-1.07 db HL (decibel Hearing Level)
Standard Deviation 7.98
|
|
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
1.5 kHz, 6 months
|
-3.39 db HL (decibel Hearing Level)
Standard Deviation 7.34
|
|
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
2.0 kHz, 6 months
|
-4.64 db HL (decibel Hearing Level)
Standard Deviation 10.97
|
|
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
3.0 kHz, 6 months
|
-3.04 db HL (decibel Hearing Level)
Standard Deviation 12.35
|
|
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
4.0 kHz, 6 months
|
-7.32 db HL (decibel Hearing Level)
Standard Deviation 11.26
|
|
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
6.0 kHz, 6 months
|
-13.9 db HL (decibel Hearing Level)
Standard Deviation 13.6
|
|
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
8.0 kHz, 6 months
|
2.86 db HL (decibel Hearing Level)
Standard Deviation 17.87
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform the test at all visits.
Signal-to-noise ratio, 50% speech understanding
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
4 weeks
|
-0.870 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 1.366
|
|
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
3 months
|
-1.21 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 1.42
|
|
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
6 months
|
-0.846 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 1.587
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform all tests at all visits.
% correctly perceived words at 50dB, 65dB and 80dB SPL
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
Speech in quiet at 50 dB, 4 weeks
|
12.2 Percentage of correct words
Standard Deviation 18.3
|
|
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
Speech in quiet at 65 dB, 4 weeks
|
9.77 Percentage of correct words
Standard Deviation 14.76
|
|
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
Speech in quiet at 80 dB, 4 weeks
|
2.88 Percentage of correct words
Standard Deviation 10.21
|
|
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
Speech in quiet at 50 dB, 3 months
|
13.2 Percentage of correct words
Standard Deviation 18.8
|
|
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
Speech in quiet at 65 dB, 3 months
|
10.1 Percentage of correct words
Standard Deviation 16.0
|
|
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
Speech in quiet at 80 dB, 3 months
|
2.66 Percentage of correct words
Standard Deviation 10.13
|
|
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
Speech in quiet at 50 dB, 6 months
|
10.7 Percentage of correct words
Standard Deviation 18.3
|
|
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
Speech in quiet at 65 dB, 6 months
|
8.84 Percentage of correct words
Standard Deviation 15.22
|
|
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
Speech in quiet at 80 dB, 6 months
|
4.00 Percentage of correct words
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3 months and 6 months after surgeryPopulation: Some participants did not perform the test at all visits.
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Outcome measures
| Measure |
Osia 2 System
n=28 Participants
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.
|
|---|---|
|
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
BC Direct 250 Hz, baseline
|
13.2 db HL (decibel Hearing Level)
Standard Deviation 10.2
|
|
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
BC Direct 500 Hz, baseline
|
24.7 db HL (decibel Hearing Level)
Standard Deviation 11.3
|
|
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
BC Direct 750 Hz, baseline
|
20.7 db HL (decibel Hearing Level)
Standard Deviation 12.4
|
|
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
BC Direct 1000 Hz, baseline
|
20.0 db HL (decibel Hearing Level)
Standard Deviation 13.5
|
|
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
BC Direct 1500 Hz, baseline
|
19.1 db HL (decibel Hearing Level)
Standard Deviation 14.6
|
|
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
BC Direct 2000 Hz, baseline
|
31.2 db HL (decibel Hearing Level)
Standard Deviation 15.3
|
|
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
BC Direct 3000 Hz, baseline
|
36.8 db HL (decibel Hearing Level)
Standard Deviation 18.7
|
|
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
BC Direct 4000 Hz, baseline
|
43.5 db HL (decibel Hearing Level)
Standard Deviation 17.6
|
|
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
BC Direct 6000 Hz, baseline
|
46.1 db HL (decibel Hearing Level)
Standard Deviation 17.6
|
|
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
BC Direct 250 Hz, 4 weeks
|
5.18 db HL (decibel Hearing Level)
Standard Deviation 12.87
|
|
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
BC Direct 500 Hz, 4 weeks
|
14.5 db HL (decibel Hearing Level)
Standard Deviation 8.7
|
|
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
BC Direct 750 Hz, 4 weeks
|
5.71 db HL (decibel Hearing Level)
Standard Deviation 11.20
|
|
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
BC Direct 1000 Hz, 4 weeks
|
9.46 db HL (decibel Hearing Level)
Standard Deviation 11.33
|
|
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
BC Direct 1500 Hz, 4 weeks
|
7.50 db HL (decibel Hearing Level)
Standard Deviation 13.23
|
|
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
BC Direct 2000 Hz, 4 weeks
|
12.0 db HL (decibel Hearing Level)
Standard Deviation 14.2
|
|
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
BC Direct 3000 Hz, 4 weeks
|
13.9 db HL (decibel Hearing Level)
Standard Deviation 15.4
|
|
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
BC Direct 4000 Hz, 4 weeks
|
23.8 db HL (decibel Hearing Level)
Standard Deviation 17.1
|
|
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
BC Direct 6000 Hz, 4 weeks
|
22.0 db HL (decibel Hearing Level)
Standard Deviation 18.7
|
|
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
BC Direct 250 Hz, 3 months
|
4.00 db HL (decibel Hearing Level)
Standard Deviation 11.21
|
|
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
BC Direct 500 Hz, 3 months
|
13.0 db HL (decibel Hearing Level)
Standard Deviation 9.8
|
|
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
BC Direct 750 Hz, 3 months
|
4.33 db HL (decibel Hearing Level)
Standard Deviation 12.08
|
|
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
BC Direct 1000 Hz, 3 months
|
9.67 db HL (decibel Hearing Level)
Standard Deviation 13.29
|
|
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
BC Direct 1500 Hz, 3 months
|
6.67 db HL (decibel Hearing Level)
Standard Deviation 15.43
|
|
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
BC Direct 2000 Hz, 3 months
|
14.0 db HL (decibel Hearing Level)
Standard Deviation 15.9
|
|
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
BC Direct 3000 Hz, 3 months
|
13.3 db HL (decibel Hearing Level)
Standard Deviation 18.5
|
|
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
BC Direct 4000 Hz, 3 months
|
24.3 db HL (decibel Hearing Level)
Standard Deviation 17.4
|
|
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
BC Direct 6000 Hz, 3 months
|
27.0 db HL (decibel Hearing Level)
Standard Deviation 18.5
|
|
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
BC Direct 250 Hz, 6 months
|
8.10 db HL (decibel Hearing Level)
Standard Deviation 13.83
|
|
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
BC Direct 500 Hz, 6 months
|
15.0 db HL (decibel Hearing Level)
Standard Deviation 8.5
|
|
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
BC Direct 750 Hz, 6 months
|
6.90 db HL (decibel Hearing Level)
Standard Deviation 12.60
|
|
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
BC Direct 1000 Hz, 6 months
|
10.7 db HL (decibel Hearing Level)
Standard Deviation 11.3
|
|
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
BC Direct 1500 Hz, 6 months
|
5.95 db HL (decibel Hearing Level)
Standard Deviation 13.84
|
|
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
BC Direct 2000 Hz, 6 months
|
14.3 db HL (decibel Hearing Level)
Standard Deviation 13.7
|
|
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
BC Direct 3000 Hz, 6 months
|
13.6 db HL (decibel Hearing Level)
Standard Deviation 17.0
|
|
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
BC Direct 4000 Hz, 6 months
|
25.7 db HL (decibel Hearing Level)
Standard Deviation 16.9
|
|
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
BC Direct 6000 Hz, 6 months
|
25.0 db HL (decibel Hearing Level)
Standard Deviation 18.8
|
Adverse Events
Osia 2 System
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Osia 2 System
n=29 participants at risk
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.
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
3.4%
1/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Infections and infestations
Infected Skin/ Wound With Subcutaneous Collection
|
3.4%
1/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Infections and infestations
Infected Wound/Possible Flap Compromise
|
3.4%
1/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Cardiac disorders
Preoperative Bradycardia
|
3.4%
1/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
Other adverse events
| Measure |
Osia 2 System
n=29 participants at risk
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.
|
|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
17.2%
5/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
General disorders
General disorders and administration site conditions - Other
|
17.2%
5/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Infections and infestations
Wound infection
|
13.8%
4/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Injury, poisoning and procedural complications
Wound complication
|
20.7%
6/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.9%
2/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
|
Psychiatric disorders
Psychiatric Disorders - Other
|
6.9%
2/29 • Number of events 29 • 6 months
Adverse events are presented by the CTCAE term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER