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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bonebridge | Active Comparator | Implantation with a Bonebridge |
|
| Bone Anchored Hearing Aid | Active Comparator | Implantation with a Bone Anchored Hearing Aid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bonebridge | Device |
| ||
| Bone Anchored Hearing Aid |
| Measure | Description | Time Frame |
|---|---|---|
| Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists | We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices | Up to 1 year post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Speech audiogram result at 60 dB A in noise using AB word lists | 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. | Up to 1 year after implantation |
| Patient reported outcome data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen EM Jones | NHS Tayside | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninewells Hospital and Medical School | Dundee | DD1 9SY | United Kingdom |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires |
| Up to 1 year following implantation |
| Time from surgery to device switch-on | The time (measured in days) will be recorded from the date of implantation to the date of its switch-on. | Up to 3 months |
| Number of patient episodes required during study period | 1 year from implantation |
| Time to complete wound healing | Measured in days, as judged subjectively by ENT medical and nursing staff | Up to 3 months from implantation |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |