Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

NCT05265260 | Completed Results

• 1 other identifier: EMEA5798
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

Cochlear implant; Sentence recognition; Cognitive processing; Electrophysiology

Outcome Measures

Primary Outcomes (1)

• Score of the French MBAA2 Sentence Recognition Test in Quiet

  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.

  1 month post activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.

You may qualify if:

• 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.

You may not qualify if:

• Subjects with single-sided deafness (SSD).
• Subjects who are not affiliated to the French Social Security.
• Subjects who are under legal protection.

Sponsors & Collaborators

• Cochlear: lead
• EVAMED: collaborator

Study Sites (1)

Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Study Officials

• Mathieu Marx, MD

  Hôpital Pierre-Paul Riquet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 3, 2022
• Study Start: April 21, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)