Trial Outcomes & Findings for Clinical Performance of a New Implant System for Bone Conduction Hearing (NCT NCT03086135)
NCT ID: NCT03086135
Last Updated: 2021-10-14
Results Overview
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
COMPLETED
NA
51 participants
Baseline before surgery, 3 months after surgery
2021-10-14
Participant Flow
Participant milestones
| Measure |
Bone-conduction Hearing Device
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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Overall Study
STARTED
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51
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Overall Study
COMPLETED
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48
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Bone-conduction Hearing Device
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lost to Follow-up
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2
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Baseline Characteristics
Clinical Performance of a New Implant System for Bone Conduction Hearing
Baseline characteristics by cohort
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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Age, Continuous
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47.4 years
STANDARD_DEVIATION 14.7 • n=5 Participants
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Sex: Female, Male
Female
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24 Participants
n=5 Participants
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Sex: Female, Male
Male
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27 Participants
n=5 Participants
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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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0 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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51 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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0 Participants
n=5 Participants
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Region of Enrollment
Netherlands
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9 participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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Region of Enrollment
Poland
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10 participants
n=5 Participants
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Region of Enrollment
Australia
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12 participants
n=5 Participants
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Region of Enrollment
Germany
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline before surgery, 3 months after surgeryThe change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=49 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
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-25.8 dB (Decibel)
Standard Deviation 9.1
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PRIMARY outcome
Timeframe: Baseline before surgery, 3 months after surgeryThe change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=48 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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|---|---|
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Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
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-13.3 SNR (Speech in Noise Ratio)
Standard Deviation 8.3
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SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 6 and 12 months after surgeryPopulation: Some subjects did not perform the test at one or more visits.
The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
4 weeks
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-24.9 dB
Standard Deviation 9.4
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Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
6 months
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-27.9 dB
Standard Deviation 9.1
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Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
12 months
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-30.4 dB
Standard Deviation 8.9
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SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.Population: 750, 1500 and 8000 Hz were not included in the eCRF for free-field threshold audiometry test due to an error when the first six subjects entered the study. Measurements at these frequencies were therefore not performed at the first visits. In addition; not all subjects performed the test at all frequencies at all visits.
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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|---|---|
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 250 Hz
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-10.3 dB (Decibel)
Standard Deviation 12.9
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 500 Hz
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-23.3 dB (Decibel)
Standard Deviation 11.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 750 Hz
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-28.3 dB (Decibel)
Standard Deviation 12.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 1000 Hz
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-26.4 dB (Decibel)
Standard Deviation 11.2
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 1500 Hz
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-24.2 dB (Decibel)
Standard Deviation 12.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 2000 Hz
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-23.8 dB (Decibel)
Standard Deviation 11.5
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 3000 Hz
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-24.7 dB (Decibel)
Standard Deviation 11.3
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 4000 Hz
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-26.1 dB (Decibel)
Standard Deviation 10.5
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 6000 Hz
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-29.6 dB (Decibel)
Standard Deviation 11.3
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks: 8000 Hz
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-29.8 dB (Decibel)
Standard Deviation 12.5
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 250 Hz
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-10.8 dB (Decibel)
Standard Deviation 13.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 500 Hz
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-23.9 dB (Decibel)
Standard Deviation 11.3
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 750 Hz
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-28.5 dB (Decibel)
Standard Deviation 12.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 1000 Hz
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-27.4 dB (Decibel)
Standard Deviation 11.9
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 1500 Hz
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-25.1 dB (Decibel)
Standard Deviation 10.6
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 2000 Hz
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-24.9 dB (Decibel)
Standard Deviation 11.0
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 3000 Hz
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-26.1 dB (Decibel)
Standard Deviation 10.7
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 4000 Hz
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-26.8 dB (Decibel)
Standard Deviation 10.6
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 6000 Hz
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-31.7 dB (Decibel)
Standard Deviation 11.2
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 8000 Hz
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-30.9 dB (Decibel)
Standard Deviation 13.8
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 250 Hz
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-11.9 dB (Decibel)
Standard Deviation 11.9
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 500 Hz
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-26.2 dB (Decibel)
Standard Deviation 11.3
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 750 Hz
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-30.4 dB (Decibel)
Standard Deviation 12.0
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 1000 Hz
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-28.9 dB (Decibel)
Standard Deviation 11.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 1500 Hz
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-28.0 dB (Decibel)
Standard Deviation 12.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 2000 Hz
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-26.1 dB (Decibel)
Standard Deviation 10.9
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 3000 Hz
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-27.6 dB (Decibel)
Standard Deviation 10.8
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 4000 Hz
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-30.2 dB (Decibel)
Standard Deviation 11.2
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 6000 Hz
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-31.6 dB (Decibel)
Standard Deviation 10.6
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 8000 Hz
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-33.7 dB (Decibel)
Standard Deviation 12.3
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 250 Hz
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-14.7 dB (Decibel)
Standard Deviation 12.8
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 500 Hz
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-27.8 dB (Decibel)
Standard Deviation 10.9
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 750 Hz
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-31.8 dB (Decibel)
Standard Deviation 11.6
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 1000 Hz
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-31.8 dB (Decibel)
Standard Deviation 10.6
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 1500 Hz
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-31.2 dB (Decibel)
Standard Deviation 12.1
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 2000 Hz
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-28.8 dB (Decibel)
Standard Deviation 11.1
|
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 3000 Hz
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-29.6 dB (Decibel)
Standard Deviation 12.0
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 4000 Hz
|
-33.0 dB (Decibel)
Standard Deviation 12.2
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 6000 Hz
|
-35.9 dB (Decibel)
Standard Deviation 11.6
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Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 8000 Hz
|
-38.8 dB (Decibel)
Standard Deviation 12.0
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SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.Population: Some of the subjects did not perform the test at one or more visits.
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL \[% correctly perceived words at 50, 65 and 80 dB SPL\] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=49 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
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|---|---|
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks; 50 dB
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38.0 Percentage of correctly perceived words
Standard Deviation 27.0
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks; 65 dB
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59.8 Percentage of correctly perceived words
Standard Deviation 28.8
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
4 weeks; 80 dB
|
29.3 Percentage of correctly perceived words
Standard Deviation 30.8
|
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 50 dB
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40.1 Percentage of correctly perceived words
Standard Deviation 26.8
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 65 dB
|
60.6 Percentage of correctly perceived words
Standard Deviation 26.8
|
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
3 months: 80 dB
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31.8 Percentage of correctly perceived words
Standard Deviation 31.9
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 50 dB
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46.5 Percentage of correctly perceived words
Standard Deviation 29.5
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 65 dB
|
61.5 Percentage of correctly perceived words
Standard Deviation 27.7
|
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Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
6 months: 80 dB
|
30.7 Percentage of correctly perceived words
Standard Deviation 33.3
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 50 dB
|
57.8 Percentage of correctly perceived words
Standard Deviation 24.9
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 65 dB
|
68.3 Percentage of correctly perceived words
Standard Deviation 23.6
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
12 months: 80 dB
|
32.7 Percentage of correctly perceived words
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 6 and 12 months after surgeryPopulation: Some subjects did not perform the test at one or more visits.
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=49 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
4 weeks
|
-12.1 SNR (Speech in Noise Ratio)
Standard Deviation 8.1
|
|
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
6 months
|
-13.7 SNR (Speech in Noise Ratio)
Standard Deviation 8.1
|
|
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
12 months
|
-13.6 SNR (Speech in Noise Ratio)
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline before surgery, 3 and 12 months after surgeryPopulation: Some of the subjects did not answer some of the questions at one or more visits.
The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=48 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
3 months: Global
|
26.1 units on a scale
Standard Deviation 18.5
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
12 months: Reverberation
|
25.4 units on a scale
Standard Deviation 25.8
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
3 months: Ease of communication
|
24.1 units on a scale
Standard Deviation 21.7
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
3 months: Background noise
|
29.4 units on a scale
Standard Deviation 20.0
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
3 months: Reverberation
|
25.8 units on a scale
Standard Deviation 23.1
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
3 months: Aversiveness
|
-2.2 units on a scale
Standard Deviation 22.3
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
12 months: Ease of communication
|
24.0 units on a scale
Standard Deviation 19.1
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
12 months: Background noise
|
29.6 units on a scale
Standard Deviation 20.9
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
12 months: Aversiveness
|
-3.58 units on a scale
Standard Deviation 24.6
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
12 months: Global
|
26.3 units on a scale
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Baseline before surgery and 3 and 12 months after surgeryPopulation: Some of the subjects did not answer all questions in the questionnaire at one or both time-points.
The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=48 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: comprehensive health state
|
0.081 units on a scale
Standard Deviation 0.227
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Vision
|
-0.006 units on a scale
Standard Deviation 0.035
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Hearing
|
0.173 units on a scale
Standard Deviation 0.324
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Speech
|
0.033 units on a scale
Standard Deviation 0.129
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Ambulation
|
-0.018 units on a scale
Standard Deviation 0.063
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Dexterity
|
0.000 units on a scale
Standard Deviation 0.000
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Emotion
|
0.016 units on a scale
Standard Deviation 0.120
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Cognition
|
0.013 units on a scale
Standard Deviation 0.088
|
|
Health Utility Index (HUI) at 3 and 12 Months
3 months: Pain
|
0.007 units on a scale
Standard Deviation 0.258
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: comprehensive health state
|
0.058 units on a scale
Standard Deviation 0.243
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Vision
|
-0.011 units on a scale
Standard Deviation 0.055
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Hearing
|
0.149 units on a scale
Standard Deviation 0.300
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Speech
|
0.062 units on a scale
Standard Deviation 0.136
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Ambulation
|
-0.024 units on a scale
Standard Deviation 0.094
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Dexterity
|
-0.011 units on a scale
Standard Deviation 0.122
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Emotion
|
0.004 units on a scale
Standard Deviation 0.144
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Cognition
|
0.001 units on a scale
Standard Deviation 0.125
|
|
Health Utility Index (HUI) at 3 and 12 Months
12 months: Pain
|
-0.029 units on a scale
Standard Deviation 0.334
|
SECONDARY outcome
Timeframe: Baseline before surgery and 3 and 12 months after surgeryPopulation: Some of the subjects did not answer all questions at one or both visits.
The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=48 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
3 months: Total score
|
2.57 units on a scale
Standard Deviation 2.01
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
3 months: Speech score
|
2.91 units on a scale
Standard Deviation 2.19
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
3 months: Spatial score
|
2.85 units on a scale
Standard Deviation 2.50
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
3 months: Quality score
|
1.88 units on a scale
Standard Deviation 2.38
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
12 months: Total score
|
2.69 units on a scale
Standard Deviation 1.75
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
12 months: Speech score
|
2.94 units on a scale
Standard Deviation 1.94
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
12 months: Spatial score
|
2.95 units on a scale
Standard Deviation 2.52
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
12 months: Quality score
|
2.13 units on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3, 6 and 12 months.Population: Some of the subjects did not perform a PTA4 measurement at one or more visits.
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
4 weeks
|
-3.16 dB
Standard Deviation 5.68
|
|
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
3 months
|
-3.82 dB
Standard Deviation 5.94
|
|
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
6 months
|
-5.72 dB
Standard Deviation 5.84
|
|
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
12 months
|
-7.85 dB
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.Population: Some of the subjects did not perform all measurements at all visits.
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 8000 Hz
|
-18.1 dB
Standard Deviation 18.4
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 4000 Hz
|
-11.9 dB
Standard Deviation 10.4
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 500 Hz
|
-5.91 dB
Standard Deviation 8.79
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 750 Hz
|
-5.75 dB
Standard Deviation 8.65
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 4000 Hz
|
-14.6 dB
Standard Deviation 10.8
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 250 hz
|
3.58 dB
Standard Deviation 10.98
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 500 Hz
|
-2.22 dB
Standard Deviation 9.15
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 750 Hz
|
-3.30 dB
Standard Deviation 8.49
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 1000 Hz
|
0.42 dB
Standard Deviation 6.65
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 1500 Hz
|
-0.48 dB
Standard Deviation 8.39
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 2000 Hz
|
-2.62 dB
Standard Deviation 7.66
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 3000 Hz
|
-3.18 dB
Standard Deviation 7.86
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 4000 Hz
|
-8.20 dB
Standard Deviation 9.58
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 6000 Hz
|
-12.5 dB
Standard Deviation 10.3
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
4 weeks: 8000 Hz
|
-16.4 dB
Standard Deviation 17.3
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 250 Hz
|
3.20 dB
Standard Deviation 9.19
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 500 Hz
|
-2.69 dB
Standard Deviation 8.86
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 750 Hz
|
-2.86 dB
Standard Deviation 8.66
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 1000 Hz
|
-0.47 dB
Standard Deviation 7.22
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 1500 Hz
|
-1.19 dB
Standard Deviation 7.82
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 2000 Hz
|
-3.37 dB
Standard Deviation 8.15
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 3000 Hz
|
-4.57 dB
Standard Deviation 9.11
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 4000 Hz
|
-8.73 dB
Standard Deviation 10.07
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
3 months: 6000 Hz
|
-15.0 dB
Standard Deviation 9.9
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 250 Hz
|
2.10 dB
Standard Deviation 8.70
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 500 Hz
|
-4.69 dB
Standard Deviation 8.90
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 750 Hz
|
-4.70 dB
Standard Deviation 7.90
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 1000 Hz
|
-1.67 dB
Standard Deviation 7.03
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 1500 Hz
|
-4.00 dB
Standard Deviation 7.23
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 2000 Hz
|
-4.61 dB
Standard Deviation 8.29
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 3000 Hz
|
-5.76 dB
Standard Deviation 8.06
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 6000 Hz
|
-14.4 dB
Standard Deviation 10.7
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
6 months: 8000 Hz
|
-20.7 dB
Standard Deviation 17.6
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 250 Hz
|
-0.39 dB
Standard Deviation 9.81
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 1000 Hz
|
-4.07 dB
Standard Deviation 7.98
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 1500 Hz
|
-6.73 dB
Standard Deviation 8.21
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 2000 Hz
|
-6.80 dB
Standard Deviation 8.33
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 3000 Hz
|
-7.61 dB
Standard Deviation 9.13
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 6000 Hz
|
-18.6 dB
Standard Deviation 11.4
|
|
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
12 months: 8000 Hz
|
-26.5 dB
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.Population: Some of the subjects did not perform all measurements at all visits.
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet \[% correctly perceived words at 50, 65 and 80 dB SPL\]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=48 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
3 months: 80 dB SPL
|
1.77 Percentage of correctly perceived words
Standard Deviation 8.35
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
6 months: 50 dB SPL
|
10.3 Percentage of correctly perceived words
Standard Deviation 24.4
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
12 months: 80 dB SPL
|
3.61 Percentage of correctly perceived words
Standard Deviation 10.45
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
4 weeks: 50 dB SPL
|
2.40 Percentage of correctly perceived words
Standard Deviation 24.81
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
4 weeks: 65 dB SPL
|
6.65 Percentage of correctly perceived words
Standard Deviation 19.58
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
4 weeks: 80 dB SPL
|
1.17 Percentage of correctly perceived words
Standard Deviation 7.34
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
3 months: 50 dB SPL
|
5.17 Percentage of correctly perceived words
Standard Deviation 26.16
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
3 months: 65 dB SPL
|
7.48 Percentage of correctly perceived words
Standard Deviation 21.39
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
6 months: 65 dB SPL
|
7.73 Percentage of correctly perceived words
Standard Deviation 22.56
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
6 months: 80 dB SPL
|
0.875 Percentage of correctly perceived words
Standard Deviation 10.02
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
12 months: 50 dB SPL
|
20.7 Percentage of correctly perceived words
Standard Deviation 29.5
|
|
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
12 months: 65 dB SPL
|
13.9 Percentage of correctly perceived words
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.Population: Some of the subjects did not perform the test at all visits.
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=47 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Adaptive Speech Recognition in Noise, With Reference Device BP110
4 weeks
|
-6.12 SNR
Standard Deviation 6.92
|
|
Adaptive Speech Recognition in Noise, With Reference Device BP110
3 months
|
-7.19 SNR
Standard Deviation 6.80
|
|
Adaptive Speech Recognition in Noise, With Reference Device BP110
6 months
|
-7.91 SNR
Standard Deviation 6.80
|
|
Adaptive Speech Recognition in Noise, With Reference Device BP110
12 months
|
-7.54 SNR
Standard Deviation 7.99
|
SECONDARY outcome
Timeframe: Visit 2, surgerySurgery time in minutes between first incision and last suture
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Surgical Information: Time of Surgery
|
97.2 minutes
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: Visit 2, surgerySurgical information: Soft tissue thickness was measured in mm
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Soft Tissue Thickness
|
6.00 mm
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Visit 2, surgerySurgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for "Yes" or "No".
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Soft Tissue Reduction
Yes
|
10 Participants
|
|
Soft Tissue Reduction
No
|
41 Participants
|
SECONDARY outcome
Timeframe: Visit 2, surgerySurgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Bone Polishing/Removal at Implant Site
Yes
|
42 Participants
|
|
Bone Polishing/Removal at Implant Site
No
|
9 Participants
|
SECONDARY outcome
Timeframe: Visit 2, surgerySurgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Type of Anaesthesia
General
|
51 Participants
|
|
Type of Anaesthesia
Local
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 2, surgeryPopulation: Localization of the BI300 implant measured in two different ways; 6 subjects with alternative 1, 45 subjects with alternative 2.
Surgical information: where is the location of the BI300 implant, measured in two different ways: Alternative 1 used for the first 6 subjects: Location from the ear channel in mm. Alternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil. Value 9.64 mm vertically from ear channel is correct.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Location of BI300 Implant
Alt 1: distance from the ear channel
|
48.3 mm
Standard Deviation 10.3
|
|
Location of BI300 Implant
9.64Alt 2: horizontally from ear channel
|
40.0 mm
Standard Deviation 17.9
|
|
Location of BI300 Implant
Alt 2: vertically from the ear channel
|
9.64 mm
Standard Deviation 9.20
|
|
Location of BI300 Implant
Alt 2: distance between receiver and coil
|
54.4 mm
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Visit 2, surgeryPopulation: For two subjects two alternatives were checked.
Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=51 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Incision Type
C-shaped flap
|
30 Participants
|
|
Incision Type
Poesterior flap
|
1 Participants
|
|
Incision Type
Other
|
22 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3, 6 and 12 monthsPopulation: Some of the subjects did not answer the question at all visits.
Sound processor usage time measured as hours per day.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Daily Usage Time of Sound Processor
6 weeks
|
10.7 hours per day
Standard Deviation 3.8
|
|
Daily Usage Time of Sound Processor
3 months
|
10.5 hours per day
Standard Deviation 4.3
|
|
Daily Usage Time of Sound Processor
6 months
|
10.6 hours per day
Standard Deviation 4.6
|
|
Daily Usage Time of Sound Processor
12 months
|
11.3 hours per day
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 6 weeks, 3, 6 and 12 monthsPopulation: Some of the subjects did not answer the question at all visits.
Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Comfort
6 weeks
|
77.3 units on a scale
Standard Deviation 18.6
|
|
Comfort
3 months
|
80.8 units on a scale
Standard Deviation 16.6
|
|
Comfort
6 months
|
78.2 units on a scale
Standard Deviation 20.1
|
|
Comfort
12 months
|
80.9 units on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 4, 6 weeks, 3, 6 and 12 monthsPopulation: Some of the subjects did not perform all visits.
Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Magnet Choice
4 weeks: strength 1/2
|
0 Participants
|
|
Magnet Choice
4 weeks: strength 1
|
1 Participants
|
|
Magnet Choice
4 weeks: strength 2
|
11 Participants
|
|
Magnet Choice
4 weeks: strength 3
|
13 Participants
|
|
Magnet Choice
4 weeks: strength 4
|
12 Participants
|
|
Magnet Choice
4 weeks: strength 5
|
8 Participants
|
|
Magnet Choice
4 weeks: strength 6
|
5 Participants
|
|
Magnet Choice
6 weeks strength 1/2
|
0 Participants
|
|
Magnet Choice
6 weeks strength 1
|
1 Participants
|
|
Magnet Choice
6 weeks strength 2
|
10 Participants
|
|
Magnet Choice
6 weeks strength 3
|
11 Participants
|
|
Magnet Choice
6 weeks strength 4
|
13 Participants
|
|
Magnet Choice
6 weeks strength 5
|
9 Participants
|
|
Magnet Choice
6 weeks strength 6
|
5 Participants
|
|
Magnet Choice
3 months strength 1/2
|
0 Participants
|
|
Magnet Choice
3 months strength 1
|
1 Participants
|
|
Magnet Choice
3 months strength 2
|
12 Participants
|
|
Magnet Choice
3 months strength 3
|
10 Participants
|
|
Magnet Choice
3 months strength 4
|
14 Participants
|
|
Magnet Choice
3 months strength 5
|
8 Participants
|
|
Magnet Choice
3 months strength 6
|
5 Participants
|
|
Magnet Choice
6 months strength 1/2
|
0 Participants
|
|
Magnet Choice
6 months strength 1
|
2 Participants
|
|
Magnet Choice
6 months strength 2
|
11 Participants
|
|
Magnet Choice
6 months strength 3
|
11 Participants
|
|
Magnet Choice
6 months strength 4
|
13 Participants
|
|
Magnet Choice
6 months strength 5
|
10 Participants
|
|
Magnet Choice
6 months strength 6
|
3 Participants
|
|
Magnet Choice
12 months strength 1/2
|
0 Participants
|
|
Magnet Choice
12 months strength 1
|
2 Participants
|
|
Magnet Choice
12 months strength 2
|
12 Participants
|
|
Magnet Choice
12 months strength 3
|
10 Participants
|
|
Magnet Choice
12 months strength 4
|
11 Participants
|
|
Magnet Choice
12 months strength 5
|
10 Participants
|
|
Magnet Choice
12 months strength 6
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3, 6 and 12 monthsPopulation: Some of the subjects did not answer the question at all visits.
A question was asked if the subjects used softpads; yes or no could be ticked.
Outcome measures
| Measure |
Bone-conduction Hearing Device
n=50 Participants
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Softpad Use
6 weeks: yes
|
1 Participants
|
|
Softpad Use
6 weeks: no
|
47 Participants
|
|
Softpad Use
3 months: yes
|
4 Participants
|
|
Softpad Use
3 months: no
|
45 Participants
|
|
Softpad Use
6 months: yes
|
0 Participants
|
|
Softpad Use
6 months: no
|
50 Participants
|
|
Softpad Use
12 months: yes
|
3 Participants
|
|
Softpad Use
12 months: no
|
44 Participants
|
Adverse Events
Bone-conduction Hearing Device
Serious adverse events
| Measure |
Bone-conduction Hearing Device
n=51 participants at risk
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Infections and infestations
Wound infection
|
2.0%
1/51 • Number of events 51 • 1 year
|
|
Infections and infestations
Infection and infestations
|
2.0%
1/51 • Number of events 51 • 1 year
|
|
Cardiac disorders
Atrial fibrilation
|
2.0%
1/51 • Number of events 51 • 1 year
|
Other adverse events
| Measure |
Bone-conduction Hearing Device
n=51 participants at risk
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
|
|---|---|
|
Ear and labyrinth disorders
Hearing impaired
|
35.3%
18/51 • Number of events 19 • 1 year
|
|
General disorders
General disorders and administration site conditions other
|
27.5%
14/51 • Number of events 15 • 1 year
|
|
Infections and infestations
Otitis externa
|
7.8%
4/51 • Number of events 4 • 1 year
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 3 • 1 year
|
|
Nervous system disorders
Nervous system disorders other
|
5.9%
3/51 • Number of events 4 • 1 year
|
Additional Information
Professor Emmanuel Mylanus
Radboud University Medical center, Nijmegen
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60