CompletedNot Applicable

Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants

Netherlands64 participantsStarted 2014-12-02

Plain-language summary

The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patient, i.e. ≥ 18 years of age * Eligible for the Ponto system Exclusion Criteria: * 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.

What they're measuring

Incidence of inflammation (Holgers index ≥ 2)

Timeframe: 3 months post surgery

Trial details

NCT IDNCT02438618

SponsorOticon Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-20

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