N/A
N=32
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
Sensorineural Hearing Loss, Bilateral
Bottom Line
View on ClinicalTrials.gov: NCT05265260 ↗Enrolled (actual)
32
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Score of the French MBAA2 Sentence Recognition Test in Quiet — 13; 19 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score of the French MBAA2 Sentence Recognition Test in Quiet |
13; 19 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05265260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.