Skip to main content
OpenTrials
Completed

NCT Number: NCT05488535

Non-significant Risk Study of a Cochlear Implant Headpiece

This study aims to evaluate a cochlear implant headpiece.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Primary location

Advanced Bionics

Valencia, California, 91355, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cochlear implant headpiece

Device

investigational cochlear implant headpiece

Primary outcomes

  1. Subjective Report of Headpiece Comfort and Retention

    Time frame: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.

    Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out.

    The baseline/investigational headpiece questionnaires included 2 questions:

    • Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
    • Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2022
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.