Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHealing cap II
Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible for treatment with a bone anchored hearing aid * 18 years or older
Exclusion criteria
* Inability to participate in follow-up * Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin reactions according to Holgers | At time of sugical follow up visit (visit window of 7-14 days after surgery) | Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fitting of sound processor at surgical follow-up visit | At time of surgical follow up visit (visit window of 7-14 days after surgery) | Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | Duration of study (12 months of enrollment) | — |
| Use of Healing cap II | At the surgical visit | Ease of use of Healing cap II and effect on surgical dressing |
| Surgical time | Recorded at surgery visit | Time taken to perform the 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) | — |
| Skin healing at first follow-up visit | At time of surgical follow up visit (visit window of 7-14 days after surgery) | — |
| Surgical complications | At the surgical visit | Any complications during and after surgery |
Countries
Denmark
Outcome results
None listed