Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

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Brief Title

Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

Official Title

Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

Brief Summary

      The aim of this clinical investigation is to investigate the subject´s overall preference,
      hearing performance and self-reported assessments with the Investigational device and its
      precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed
      hearing loss or Single Sided Deafness, (SSD).
    



Study Type

Interventional


Primary Outcome

Abbreviated Profile of Hearing Aid Benefit (APHAB)


Condition

Deafness; Sensoneural Single Sided

Intervention

Investigational device - Sound Processor

Study Arms / Comparison Groups

 Investigational device - Sound Processor
Description:  

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

11

Start Date

February 19, 2019

Completion Date

April 23, 2019

Primary Completion Date

April 23, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Completed clinical investigation CBAS5539, and an active user of the Osia System.

          -  Signed Informed consent.

          -  Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction
             thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL.

        OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure
        tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in
        the good ear.

        - Optimally fitted with Osia Sound processor, according to subject's experience prior to
        inclusion.

        Exclusion Criteria:

          -  Any ongoing soft tissue complication that could significantly affect the use of the
             Osia 2 Sound Processor during the 6 weeks period

          -  Use of ototoxic drugs that could be harmful to the hearing, as judged by the
             investigator

          -  Unable to follow investigational procedures and instructions, e.g. inability to
             complete quality of life scales or audiological testing as described in the Clinical
             Investigation Plan (CIP).

          -  Participation in another clinical investigation with pharmaceutical and/or device.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Cowan, Prof, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03848910

Organization ID

CBAS5731


Responsible Party

Sponsor

Study Sponsor

Cochlear Bone Anchored Solutions


Study Sponsor

Robert Cowan, Prof, Principal Investigator, HEARing CRC550, Carlton, Melbourne


Verification Date

January 2020