Evaluation of Sound Processor for a Transcutaneous System

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Brief Title

Evaluation of Sound Processor for a Transcutaneous System

Official Title

Single Center Evaluation of a Sound Processor for a Transcutaneous System

Brief Summary

      A single center study evaluating the performance of an externally worn sound processor for a
      transcutaneous bone anchored hearing system using audiological outcomes measures such as
      aided thresholds and speech intelligibility and self evaluation questionnaires.
    

Detailed Description

      Bone conduction hearing systems use the body's natural ability to transfer sound through bone
      conduction. The sound processor picks up sound and converts it into vibrations that are
      transferred through the skull bone to the inner ear (cochlea). Thus, for patients with
      conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear
      disease or malformations (such as microtia), the vibrations are bypassing the conductive
      problem in the ear canal or middle ear. Bone conduction devices currently on the market are
      divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct
      drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound
      processor used for a transcutaneous system.
    


Study Type

Interventional


Primary Outcome

Aided thresholds Fusion-unaided PTA

Secondary Outcome

 Aided thresholds Fusion-unaided

Condition

Conductive Hearing Loss

Intervention

Fusion Sound Processor

Study Arms / Comparison Groups

 Fusion sound processor
Description:  The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.

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

10

Start Date

November 15, 2017

Completion Date

November 22, 2018

Primary Completion Date

November 22, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects implanted with the Bridging Bone Conductor (BBC) implant

          -  Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction
             Implant) study

          -  Subjects available for 6 months study procedures without affecting the follow ups in
             the Osseofon BCI study

          -  Active user of the BCI SP

        Exclusion Criteria:

          -  Inability to participate in follow-ups

          -  Unsuitable as judged by the principle investigator or the sub-investigator
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Måns Eeg Olofsson, MD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT03374787

Organization ID

C58


Responsible Party

Sponsor

Study Sponsor

Oticon Medical

Collaborators

 Sahlgrenska University Hospital, Sweden

Study Sponsor

Måns Eeg Olofsson, MD, Principal Investigator, Sahlgrenska University Hospital, Sweden


Verification Date

April 2019