NCT06710236

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 25, 2024

Last Update Submit

November 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hearing instrument feature performance

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

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

Study Arms (1)

Hearing Aid Users

EXPERIMENTAL

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

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

Hearing Aid Users

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phonak Audiology Research Center

Aurora, Illinois, 60504, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Research Audiologist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants all receive the same intervention/hearing aid, but will be blinded as to which program they are being tested with.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 29, 2024

Study Start

November 18, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations