Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

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Sensorineural hearing loss
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Brief Title

Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

Official Title

Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study

Brief Summary

      The aim of this study is to understand how audiometric, cognitive and electrophysiological
      results relate to sentence recognition score in adults using currently a Nucleus cochlear
      implant.

Study Type

Observational

Primary Outcome

Score of the French MBAA2 sentence recognition test in quiet

Condition

Sensorineural Hearing Loss, Bilateral

Publications

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

Recruitment Information

Estimated Enrollment

30

Start Date

April 21, 2022

Completion Date

July 2022

Primary Completion Date

July 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Adult subjects, 18 years or older

          -  Subjects unilaterally implanted or bilaterally implanted with at least 6 months
             separating the two cochlear implantations.

          -  Subjects who have been implanted between January 2016 and December 2021.

          -  Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with
             non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating
             magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso
             2 off-the-ear types.

          -  Subjects who are fluent in French (language used in the questionnaire and speech
             tests)

          -  Subjects who are not opposed to participating in the study

          -  Subjects for who the medical record data is available throughout the defined data
             search period.

        Exclusion Criteria:

          -  Subjects with single-sided deafness (SSD).

          -  Subjects who are not affiliated to the French Social Security.

          -  Subjects who are under legal protection.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mathieu Marx, MD, +33534638584, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT05265260

Organization ID

EMEA5798

Responsible Party

Sponsor

Study Sponsor

Cochlear

Collaborators

 EVAMED

Study Sponsor

Mathieu Marx, MD, Principal Investigator, Hôpital Pierre-Paul Riquet

Verification Date

May 2022