Non-significant Risk Study of a Cochlear Implant Headpiece

Hearing Loss Clinical Trial

Official title:

Non-significant Risk Study of a Cochlear Implant Headpiece

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488535
• Other study ID #: 20190256
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: February 22, 2020

Study information

• Verified date: August 2023
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate a cochlear implant headpiece.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 22, 2020
• Est. primary completion date: February 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• cochlear implant headpiece
investigational cochlear implant headpiece

Locations

Country	Name	City	State
United States	Advanced Bionics	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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)	Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.