Clinical Performance of a New Implant System for Bone Conduction Hearing
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Deafness; Sensoneural Single Sided
- Sponsor
- Cochlear
- Enrollment
- 51
- Locations
- 5
- Primary Endpoint
- Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
Time Frame: Baseline before surgery, 3 months after surgery
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.
Time Frame: Baseline before surgery, 3 months after surgery
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 Outcomes
- Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months(Baseline before surgery, 4 weeks, 6 and 12 months after surgery)
- Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months(Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.)
- Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months(Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.)
- Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months(Baseline before surgery, 4 weeks, 6 and 12 months after surgery)
- Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months(Baseline before surgery, 3 and 12 months after surgery)
- Health Utility Index (HUI) at 3 and 12 Months(Baseline before surgery and 3 and 12 months after surgery)
- Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months(Baseline before surgery and 3 and 12 months after surgery)
- Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110(Baseline before surgery, 4 weeks, 3, 6 and 12 months.)
- Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110(Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.)
- Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110(Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.)
- Adaptive Speech Recognition in Noise, With Reference Device BP110(Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.)
- Surgical Information: Time of Surgery(Visit 2, surgery)
- Soft Tissue Thickness(Visit 2, surgery)
- Soft Tissue Reduction(Visit 2, surgery)
- Bone Polishing/Removal at Implant Site(Visit 2, surgery)
- Type of Anaesthesia(Visit 2, surgery)
- Location of BI300 Implant(Visit 2, surgery)
- Incision Type(Visit 2, surgery)
- Daily Usage Time of Sound Processor(6 weeks, 3, 6 and 12 months)
- Comfort(6 weeks, 3, 6 and 12 months)
- Magnet Choice(4, 6 weeks, 3, 6 and 12 months)
- Softpad Use(6 weeks, 3, 6 and 12 months)