Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

Completed

• Conditions: Sensorineural Hearing Loss, Bilateral

• Registration Number: NCT05265260
• Lead Sponsor: Cochlear

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-03
• Study Start: 2022-04-21
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Status Verified: 2023-10
• Results First Submitted: 2023-10-10
• Results First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Results First Posted: 2024-04-05
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of the French MBAA2 Sentence Recognition Test in Quiet	1 month post activation	Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of \<90/100 correct sentence.

Trial Locations

Locations (1)

Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique; 🇫🇷 Toulouse, France