Clinical Survey of Oticon Medical Healing Cap

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Brief Title

Clinical Survey of Oticon Medical Healing Cap

Official Title

C51 - Clinical Survey of Oticon Medical Healing Cap

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 Type

Interventional


Primary Outcome

Skin reactions according to Holgers

Secondary Outcome

 Fitting of sound processor at surgical follow-up visit

Condition

Conductive Hearing Loss

Intervention

Healing cap II

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

32

Start Date

July 2014

Completion Date

April 19, 2016

Primary Completion Date

October 2015

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Søren Foghsgaard, M.D., , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT02274129

Organization ID

C51


Responsible Party

Sponsor

Study Sponsor

Oticon Medical


Study Sponsor

Søren Foghsgaard, M.D., Principal Investigator, [email protected]


Verification Date

November 2017