Non-significant Risk Study of a Cochlear Implant Headpiece

Advanced Bionics

Status

Completed

Conditions

Hearing Loss

Sensorineural Hearing Loss

Treatments

Device: cochlear implant headpiece

Study type

Interventional

Funder types

Industry

Identifiers

NCT05488535

20190256

Details and patient eligibility

About

This study aims to evaluate a cochlear implant headpiece.

Full description

The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.

Enrollment

101 patients

Sex

All

Volunteers

No Healthy Volunteers

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.