N/A
N=101
Non-significant Risk Study of a Cochlear Implant Headpiece
Hearing Loss · Sensorineural Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05488535 ↗Enrolled (actual)
101
Serious AEs
2.0%
Results posted
Nov 2023
Primary outcome: Primary: Subjective Report of Headpiece Comfort and Retention — 65; 70 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cochlear implant headpiece (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Advanced Bionics
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Report of Headpiece Comfort and Retention |
65; 70 | — |
Summary
This study aims to evaluate a cochlear implant headpiece.
Eligibility Criteria
Inclusion Criteria
- Pre- or post-lingually deafened.
- Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
- Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
- Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
- Be able to remove their own headpiece
- Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study
- Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent
Exclusion Criteria
- Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.
Data sourced from ClinicalTrials.gov (NCT05488535). 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.