N/A
N=51
Clinical Performance of a New Implant System for Bone Conduction Hearing
Deafness; Sensoneural Single Sided · Conductive Hearing Loss · Mixed Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT03086135 ↗Enrolled (actual)
51
Serious AEs
3.9%
Results posted
Feb 2020
Primary outcome: Primary: Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months — -25.8 dB (Decibel) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Osia System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months |
-25.8 | <0.0001 sig |
| PRIMARY Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months. |
-13.3 | <0.0001 sig |
| SECONDARY Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months |
-24.9; -27.9; -30.4 | <0.0001 sig |
| SECONDARY Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months |
-10.3; -23.3; -28.3; -26.4; -24.2; -23.8 | <0.0001 sig |
| SECONDARY Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months |
38.0; 59.8; 29.3; 40.1; 60.6; 31.8 | <0.0001 sig |
| SECONDARY Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months |
-12.1; -13.7; -13.6 | <0.0001 sig |
| SECONDARY Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months |
24.1; 29.4; 25.8; -2.2; 26.1; 24.0 | <0.0001 sig |
| SECONDARY Health Utility Index (HUI) at 3 and 12 Months |
0.081; -0.006; 0.173; 0.033; -0.018; 0.000 | 0.026 sig |
| SECONDARY Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months |
2.57; 2.91; 2.85; 1.88; 2.69; 2.94 | <0.0001 sig |
| SECONDARY Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110 |
-3.16; -3.82; -5.72; -7.85 | <0.0001 sig |
| SECONDARY Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 |
3.58; -2.22; -3.30; 0.42; -0.48; -2.62 | 0.025 sig |
| SECONDARY Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 |
2.40; 6.65; 1.17; 5.17; 7.48; 1.77 | 0.51 |
| SECONDARY Adaptive Speech Recognition in Noise, With Reference Device BP110 |
-6.12; -7.19; -7.91; -7.54 | <0.0001 sig |
| SECONDARY Surgical Information: Time of Surgery |
97.2 | — |
| SECONDARY Soft Tissue Thickness |
6.00 | — |
| SECONDARY Soft Tissue Reduction |
10; 41 | — |
| SECONDARY Bone Polishing/Removal at Implant Site |
42; 9 | — |
| SECONDARY Type of Anaesthesia |
51; 0 | — |
| SECONDARY Location of BI300 Implant |
48.3; 40.0; 9.64; 54.4 | — |
| SECONDARY Incision Type |
30; 1; 22 | — |
| SECONDARY Daily Usage Time of Sound Processor |
10.7; 10.5; 10.6; 11.3 | — |
| SECONDARY Comfort |
77.3; 80.8; 78.2; 80.9 | — |
| SECONDARY Magnet Choice |
0; 1; 11; 13; 12; 8 | — |
| SECONDARY Softpad Use |
1; 47; 4; 45; 0; 50 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03086135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.