Bone Conduction Deafness, Hearing Loss, Conductive
Conditions
Keywords
Hearing Loss, Conductive, Bone Conduction, bone conduction thresholds better than 45 dBHL
Brief summary
The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.
Detailed description
The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids. There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge. The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.
Interventions
DEVICEBonebridge
Sponsors
Ninewells Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Conductive Hearing Loss within criteria for Bonebridge * Adults
Exclusion criteria
* Children * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists | Up to 1 year post-operatively | We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech audiogram result at 60 dB A in noise using AB word lists | Up to 1 year after implantation | The speech audiogram will also be carried out in noise to demonstrate whether one device gives an appreciable advantage over another with respect to understanding in noise compared to silence. |
| Patient reported outcome data | Up to 1 year following implantation | Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires |
| Time from surgery to device switch-on | Up to 3 months | The time (measured in days) will be recorded from the date of implantation to the date of its switch-on. |
| Number of patient episodes required during study period | 1 year from implantation | — |
| Time to complete wound healing | Up to 3 months from implantation | Measured in days, as judged subjectively by ENT medical and nursing staff |
Countries
United Kingdom
Outcome results
None listed