Sensorineural Hearing Loss, Bilateral
Conditions
Keywords
Cochlear implant, Sentence recognition, Cognitive processing, Electrophysiology
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.
Interventions
None listed
Sponsors
EVAMED
Cochlear
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Participant flow
Recruitment details
32 participants were recruited between 21 April 2022 and 24 August 2022. The aim was to recruit 30 participants with data for the primary endpoint. As it was noted during the data collection period that data was missing, the number was increased to 32.
Participants by arm
| Arm | Count |
|---|---|
| Adults Using Currently a Nucleus Cochlear Implant Adults (\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Adults Using Currently a Nucleus Cochlear Implant |
|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment France | 32 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 1 month post activation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults Using Currently a Nucleus Cochlear Implant | Score of the French MBAA2 Sentence Recognition Test in Quiet | Good performer | 13 Participants |
| Adults Using Currently a Nucleus Cochlear Implant | Score of the French MBAA2 Sentence Recognition Test in Quiet | Bad performer | 19 Participants |