Clinical Evaluation of a Cochlear Implant System

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Sensorineural hearing loss
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Brief Title

Clinical Evaluation of a Cochlear Implant System

Official Title

Clinical Evaluation of a Cochlear Implant System

Brief Summary

      The primary objective of this study is to assess the usability of a Cochlear implant system.

Detailed Description

      Measure participant ratings on satisfaction of a Cochlear implant system via use of validated
      and non-validated questionnaires.

Study Type

Interventional

Primary Outcome

Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.

Secondary Outcome

 Speech perception performance of the CP1000 Sound Processor in quiet and in noise.

Condition

Sensorineural Hearing Loss

Intervention

Nucleus 7 Cochlear Implant System

Study Arms / Comparison Groups

 Cochlear implant users
Description:  This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.

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

46

Start Date

July 1, 2016

Completion Date

September 7, 2017

Primary Completion Date

September 7, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Eighteen years of age or older

          2. At least 6 months experience with a Nucleus 24 series or later implant in at least one
             implanted ear

          3. At least 3 months experience with the CP810,CP920 or CP910 sound processor

          4. Fluent speaker in the language used to assess speech perception performance

          5. Willingness to participate in and to comply with all requirements of the protocol

          6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

        Exclusion Criteria:

          1. Unrealistic expectations on the part of the subject, regarding the possible benefits,
             risks and limitations that are inherent to the procedure and prosthetic device

          2. Additional disabilities that would prevent participation in evaluations

          3. Nucleus 22 Implant

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mary Beth Brinson, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT03467399

Organization ID

CLTD5620

Responsible Party

Sponsor

Study Sponsor

Cochlear

Study Sponsor

Mary Beth Brinson, Principal Investigator, Cochlear Ltd

Verification Date

March 2018