Minimally invasive surgery for Ponto bone anchored hearing implants

Phase 3

Completed

Conditions: deafness
hearing loss
10019243

Registration Number: NL-OMON44599

Lead Sponsor: Oticon Medical AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

• Adult patient, i.e. >= 18 years of age
• Eligible for the Ponto system
• Signed informed consent

Exclusion Criteria

A potential subject who meets the inclusion criteria for Ponto surgery, is willing to participate in the trial and meets any of the following criteria will be excluded from participation in this study.
- Known history of immunosuppressive disease
- Use of systemic immunosuppressive medication
- Receiving bilateral bone anchored hearing system
- Relevant dermatological diseases as judged by the investigator
- Not being able to finish the study, for example because of failure to complete the questionnaires
- Participating in another study with medical aids or medication
- When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the incidence of inflammation. Incidence of<br /><br>inflammation is calculated as the sum of patients with one or more observations<br /><br>of Holgers index of 2 or higher between surgery and 3 months post-surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>After 3 months post-surgery<br /><br>- Presence of dehiscence after surgery<br /><br>- VAS pain scale >6<br /><br>- Loss of sensibility<br /><br>- Soft tissue overgrowth<br /><br>- Extrusion rate<br /><br>- ISQ measurments<br /><br>- Skin position<br /><br>- Dynamic skin motion<br /><br>- Surgical time<br /><br>- Wound healing time<br /><br><br /><br>After 24 months post-surgery<br /><br>- Holgers index of two or higher at any timepoint<br /><br>- Presence of dehiscence after surgery<br /><br>- VAS pain scale >6<br /><br>- Loss of sensibility<br /><br>- Soft tissue overgrowth<br /><br>- Extrusion rate<br /><br>- ISQ measuremnts<br /><br>- Cosmetic result </p><br>