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


Primary Outcome

Abbreviated Profile of Hearing Aid Benefit (APHAB)


Deafness; Sensoneural Single Sided


Investigational device - Sound Processor

Study Arms / Comparison Groups

 Investigational device - Sound Processor


* 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


Estimated Enrollment


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

        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

          -  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.




18 Years - N/A

Accepts Healthy Volunteers



Robert Cowan, Prof, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Cochlear Bone Anchored Solutions

Study Sponsor

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

Verification Date

January 2020