Direct-to-Consumer Hearing Aids and Listening Effort

• Sponsor: Northwestern University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05855005
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 14.2
• Patients Per Site: 15
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral	Device: DTC Hearing Aids	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Investigation of Direct-to-consumer Hearing Aids on Conversation Efficiency and Listening Effort
• Actual Study Start Date: Oct 25, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DTC Hearing Aid	Device: DTC Hearing Aids; DTC hearing aid programmed to the individual participant.

Outcome Measures

Primary Outcome Measures

1. Diapix Conversation Task [Task is completed at first 1 day study visit, with and without hearing aids.]

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

Secondary Outcome Measures

1. Pupillometry and Recall Repeat Task (RRT) [Task will be completed at second 1 day study visit]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Speak English as their primary language

2. No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)

3. Bilateral mild to moderate sensorineural or mixed hearing loss

4. Pass a cognitive screener

5. Minimum Grade 10 education

6. Ability to attend all study visits

7. Eligible communication partner who can attend first study visit.

Exclusion Criteria:

1. 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

2. 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

3. Diagnosis of dementia or cognitive impairment

4. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)

5. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies

6. History or current fluctuating hearing loss

7. Evidence of conductive hearing loss

8. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)

9. Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611
2	Northwestern University	Evanston	Illinois	United States	60208

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Pamela Souza, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pamela Souza, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT05855005
• Other Study ID Numbers: STU00217791
• First Posted: May 11, 2023
• Last Update Posted: May 11, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Study Results

No Results Posted as of May 11, 2023