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This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Healing cap II | Experimental | Single arm study using a new healing cap as intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healing cap II | Device | Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin reactions according to Holgers | Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery. | At time of sugical follow up visit (visit window of 7-14 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Fitting of sound processor at surgical follow-up visit | Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments. | At time of surgical follow up visit (visit window of 7-14 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | Time taken to perform the surgery | Recorded at surgery visit |
| Surgical complications | Any complications during and after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Foghsgaard, M.D. | Soeren.Foghsgaard@regionh.dk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet | Gentofte Municipality | Hellerup | 2900 | Denmark | ||
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| At the surgical visit |
| Surgical complications | Any complications during and after surgery | At time of surgical follow up visit (visit window of 7-14 days after surgery) |
| Implant stability | Duration of study (12 months of enrollment) |
| Use of Healing cap II | Ease of use of Healing cap II and effect on surgical dressing | At the surgical visit |
| Use of Healing cap II | Ease of use of Healing cap II and effect on surgical dressing | At time of surgical follow up visit (visit window of 7-14 days after surgery) |
| Skin healing at first follow-up visit | At time of surgical follow up visit (visit window of 7-14 days after surgery) |
| Pain and numbness | Duration of study (12 months of enrollment) |
| Time of fitting and type of sound processor | Duration of study (12 months of enrollment) |
| Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital |
| Aalborg |
| 9000 |
| Denmark |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |