Back to resultsClinical Performance of a New Implant System for Bone Conduction Hearing
Primary Purpose
Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Osia System
Sponsored by
About this trial
This is an interventional treatment trial for Deafness; Sensoneural Single Sided
Eligibility Criteria
Inclusion Criteria:
- Adult subjects (18 years or older)
- Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
- Signed informed consent
- Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Exclusion Criteria:
- Uncontrolled diabetes as judged by the investigator.
- Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
- Insufficient bone quality and quantity for implantation of a BI300 Implant.
- Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
- Unable to follow investigational procedures, e.g. to complete quality of life scales.
- Participation in another clinical investigation with pharmaceutical and/or device.
Sites / Locations
- University of Michigan
- The Royal Victorian Eye and Ear Hospital
- University Medical Center Freiburg
- Radboud University Medical Center
- World Hearing Center Institute of Physiology and Pathology of Hearing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bone-conduction hearing device
Arm Description
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.
Outcomes
Primary Outcome Measures
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
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.
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
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 abetter hearing in a noisy enviroment.
Secondary Outcome Measures
Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
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.
Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
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.
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
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.
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
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.
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
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.
Health Utility Index (HUI) at 3 and 12 Months
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.
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
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.
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
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.
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
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.
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
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.
Adaptive Speech Recognition in Noise, With Reference Device BP110
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.
Surgical Information: Time of Surgery
Surgery time in minutes between first incision and last suture
Soft Tissue Thickness
Surgical information: Soft tissue thickness was measured in mm
Soft Tissue Reduction
Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for "Yes" or "No".
Bone Polishing/Removal at Implant Site
Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.
Type of Anaesthesia
Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.
Location of BI300 Implant
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.
Incision Type
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.
Daily Usage Time of Sound Processor
Sound processor usage time measured as hours per day.
Comfort
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.
Magnet Choice
Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.
Softpad Use
A question was asked if the subjects used softpads; yes or no could be ticked.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03086135
Brief Title
Clinical Performance of a New Implant System for Bone Conduction Hearing
Official Title
Clinical Performance of a New Implant System for Bone Conduction Hearing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
June 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone-conduction hearing device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Osia System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
Description
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.
Time Frame
Baseline before surgery, 3 months after surgery
Title
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
Description
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 abetter hearing in a noisy enviroment.
Time Frame
Baseline before surgery, 3 months after surgery
Secondary Outcome Measure Information:
Title
Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Title
Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Title
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Title
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Title
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
Description
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.
Time Frame
Baseline before surgery, 3 and 12 months after surgery
Title
Health Utility Index (HUI) at 3 and 12 Months
Description
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.
Time Frame
Baseline before surgery and 3 and 12 months after surgery
Title
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
Description
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.
Time Frame
Baseline before surgery and 3 and 12 months after surgery
Title
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 3, 6 and 12 months.
Title
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Title
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Title
Adaptive Speech Recognition in Noise, With Reference Device BP110
Description
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.
Time Frame
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Title
Surgical Information: Time of Surgery
Description
Surgery time in minutes between first incision and last suture
Time Frame
Visit 2, surgery
Title
Soft Tissue Thickness
Description
Surgical information: Soft tissue thickness was measured in mm
Time Frame
Visit 2, surgery
Title
Soft Tissue Reduction
Description
Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for "Yes" or "No".
Time Frame
Visit 2, surgery
Title
Bone Polishing/Removal at Implant Site
Description
Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.
Time Frame
Visit 2, surgery
Title
Type of Anaesthesia
Description
Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.
Time Frame
Visit 2, surgery
Title
Location of BI300 Implant
Description
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.
Time Frame
Visit 2, surgery
Title
Incision Type
Description
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.
Time Frame
Visit 2, surgery
Title
Daily Usage Time of Sound Processor
Description
Sound processor usage time measured as hours per day.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Comfort
Description
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.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Magnet Choice
Description
Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.
Time Frame
4, 6 weeks, 3, 6 and 12 months
Title
Softpad Use
Description
A question was asked if the subjects used softpads; yes or no could be ticked.
Time Frame
6 weeks, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult subjects (18 years or older)
Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
Signed informed consent
Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Exclusion Criteria:
Uncontrolled diabetes as judged by the investigator.
Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
Insufficient bone quality and quantity for implantation of a BI300 Implant.
Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
Unable to follow investigational procedures, e.g. to complete quality of life scales.
Participation in another clinical investigation with pharmaceutical and/or device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Mylanus, Prof.
Organizational Affiliation
Radboud Univerity Medical centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Briggs, Prof.
Organizational Affiliation
The Royal Victorian Eye and Ear Hospita
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Arndt, Prof.
Organizational Affiliation
Universitätsklinikum Freiburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piotr Skarżyński, Ass.Prof.
Organizational Affiliation
Center of Hearing and Speech
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Alexander Arts, Prof.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
The Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
VIC 3002
Country
Australia
Facility Name
University Medical Center Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Facility Name
World Hearing Center Institute of Physiology and Pathology of Hearing
City
Kajetany
State/Province
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of a New Implant System for Bone Conduction Hearing
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