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Not yet recruitingNCT06710236Updated Nov 29, 2024

Evaluation of Investigational Hearing Instrument Features

An interventional study of Hearing instrument in Hearing Loss, sponsored by Sonova AG. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Sonova AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 95 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:

How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?

Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.

02

Conditions studied

  • Hearing Loss

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03

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult, age 18 - 95 years
  • N4 hearing loss
  • Experienced hearing aid user
  • English fluency
  • Cognitively able to complete complex listening tasks

Exclusion criteria

Exclusion Criteria:

  • Normal hearing, or hearing loss outside the specified range
  • No hearing aid experience
  • Unable to speak, read, or write English fluently
  • Cognitive impairment
  • Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Hearing Aid Users

    Participants will wear hearing instruments for the duration of the study period. They will be asked to complete questionnaires about their environment and experience.

    Device: Hearing instrument

Interventions

  • DeviceHearing instrument

    Conventional, daily wear hearing instruments will be used in this study.

05

What researchers measure

Primary outcomes

  1. Hearing instrument feature performance

    Accuracy of hearing instrument feature performance based on environmental sampling and subjective reporting

    Time frame: From enrollment to the completion of data collection, approximately 6 weeks

06

Study locations

1 site
  • Phonak Audiology Research Center
    Aurora, Illinois 60504, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06710236
Lead sponsor
Sonova AG
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Nov 18, 2024 (estimated)
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Research Audiologist
Contact
sv.clinical@sonova.com
800-679-4871

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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