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Direct-to-Consumer Hearing Aids and Listening Effort

Primary Purpose

Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DTC Hearing Aids
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Speak English as their primary language No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration) Bilateral mild to moderate sensorineural or mixed hearing loss Pass a cognitive screener Minimum Grade 10 education Ability to attend all study visits Eligible communication partner who can attend first study visit. Exclusion Criteria: Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer Diagnosis of dementia or cognitive impairment Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression) Co-enrolled in other intervention studies targeting hearing, language, or communication strategies History or current fluctuating hearing loss Evidence of conductive hearing loss Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year) Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider

Sites / Locations

  • Northwestern UniversityRecruiting
  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DTC Hearing Aid

Arm Description

Outcomes

Primary Outcome Measures

Diapix Conversation Task
Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone.

Secondary Outcome Measures

Pupillometry and Recall Repeat Task (RRT)
Participant completes the RRT, a measure of memory and reported listening effort where the listener repeats pre-recorded sentences as they are presented and is then asked to recall them 15 seconds later. The listener also provides subjective listening effort ratings. While completing this task, the participant's pupil size will be measured.

Full Information

First Posted
May 3, 2023
Last Updated
May 10, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05855005
Brief Title
Direct-to-Consumer Hearing Aids and Listening Effort
Official Title
Investigation of Direct-to-consumer Hearing Aids on Conversation Efficiency and Listening Effort
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The aim of this proposed project is to understand whether direct to consumer (DTC) hearing aids programmed to individual hearing losses, can reduce listening effort for effective communication. If DTC aids can provide benefits beyond amplification, then they could be an affordable option to reduce barriers to care and improve hearing aid uptake in adults with hearing loss.
Detailed Description
Hearing loss is the third most common chronic health condition in the United States, affecting individuals of any age. According to the National Institute on Deafness and Other Communication Disorders approximately 15% of all adults over age 18 in the United States have reported some trouble with their hearing, and one in eight people in the United States (about 30 million) aged 12 and older have hearing loss in both ears. However, about 28.8 million US adults who could benefit from hearing aids do not wear them. The current model of dispensing hearing aids could be a barrier to adoption by those who could benefit from amplification. Possible barriers from the current model include cost and ability to visit a hearing care professional required to purchase, adjust and repair a hearing aid. The Food and Drug Administration (FDA) issued a proposal in 2021 to make hearing care more accessible for Americans, known as the Over-the-Counter Hearing Aid Act, part of the FDA Reauthorization Act of 2017. Unlike conventional hearing aids, these devices will not require appointments to an audiologist for adjustments. Due to their affordability and easy access, DTC hearing aids have the potential to reach more individuals with hearing loss. Despite the many potential benefits that DTC hearing aids could offer, there is little research into their use to meet unique patient listening needs and the accuracy of self-guided hearing aid fittings. The investigators will evaluate the benefit of DTC hearing aids via questionnaires and a conversation task the participant engages in with a familiar speaker.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DTC Hearing Aid
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DTC Hearing Aids
Intervention Description
DTC hearing aid programmed to the individual participant.
Primary Outcome Measure Information:
Title
Diapix Conversation Task
Description
Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone.
Time Frame
Task is completed at first 1 day study visit, with and without hearing aids.
Secondary Outcome Measure Information:
Title
Pupillometry and Recall Repeat Task (RRT)
Description
Participant completes the RRT, a measure of memory and reported listening effort where the listener repeats pre-recorded sentences as they are presented and is then asked to recall them 15 seconds later. The listener also provides subjective listening effort ratings. While completing this task, the participant's pupil size will be measured.
Time Frame
Task will be completed at second 1 day study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Speak English as their primary language No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration) Bilateral mild to moderate sensorineural or mixed hearing loss Pass a cognitive screener Minimum Grade 10 education Ability to attend all study visits Eligible communication partner who can attend first study visit. Exclusion Criteria: Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer Diagnosis of dementia or cognitive impairment Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression) Co-enrolled in other intervention studies targeting hearing, language, or communication strategies History or current fluctuating hearing loss Evidence of conductive hearing loss Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year) Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Marks, AuD
Phone
8474670897
Email
kendra.marks@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Szatkowski, AuD
Email
mailto:graceszatkowski2026@u.northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Souza, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Marks
Phone
847-467-0897
Email
kendra.marks@northwestern.edu
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Marks
Phone
847-467-0897
Email
kendra.marks@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Direct-to-Consumer Hearing Aids and Listening Effort

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