Clinical Survey of Oticon Medical Healing Cap

Not Applicable

Completed

• Conditions: Mixed Hearing Loss; Unilateral Partial Deafness; Conductive Hearing Loss
• Interventions: Device: Healing cap II

• Registration Number: NCT02274129
• Lead Sponsor: Oticon Medical

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Primary Completion: 2015-10
• Study Completion: 2016-04-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of Healing cap II	Healing cap II	Single arm study using a new healing cap as intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet; 🇩🇰 Gentofte, Hellerup, Denmark