Non-significant Risk Study of a Cochlear Implant Headpiece

NCT05488535 | Completed Results

• 1 other identifier: 20190256
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate a cochlear implant headpiece.

Conditions

Hearing Loss; Sensorineural Hearing Loss

Keywords

cochlear implant

Outcome Measures

Primary Outcomes (1)

• Subjective Report of Headpiece Comfort and Retention

  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: 1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable) 2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)

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

Study Arms (1)

Non-significant risk study of a cochlear implant headpiece

EXPERIMENTAL

This arm aims to evaluate a cochlear implant headpiece.

Device: cochlear implant headpiece

Interventions

cochlear implant headpiece DEVICE

investigational cochlear implant headpiece

Non-significant risk study of a cochlear implant headpiece

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Bionics: lead

Study Sites (1)

Advanced Bionics

Valencia, California, 91355, United States

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Emily Cardenas, Au.D.
• Organization: Advanced Bionics

Emily.Cardenas@advancedbionics.com

16616785405

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 4, 2022
• Study Start: February 28, 2019
• Primary Completion: February 22, 2020
• Study Completion: February 22, 2020
• Last Updated: November 14, 2023
• Results First Posted: November 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)