Direct-to-Consumer Hearing Aids and Listening Effort

NCT05855005 | Completed Results FDA Device

• 1 other identifier: STU00217791
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Diapix Conversation Task: Average Time Per Correctly Identified Difference

  Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone. Primary measurement is average time for each correctly identified difference. A decrease in time indicates improved efficiency in the task.

  Task is completed at first study visit (typically 2 hours) after hearing aid fitting, with and without hearing aids.

Secondary Outcomes (1)

• Pupillometry and Recall Repeat Task (RRT)

  Task will be completed at second study visit (about one hour). second visit usually takes place 1-2 weeks after first visit.

Study Arms (1)

DTC Hearing Aid

EXPERIMENTAL

Device: DTC Hearing Aids

Interventions

DTC Hearing Aids DEVICE

DTC hearing aid programmed to the individual participant.

DTC Hearing Aid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study only used one kind of over the counter hearing aids that only came with a few different levels of amplification. It is possible that a different OTC hearing aid or different patient population would have different outcomes. The primary outcome measure was also performed in a quiet room with a familiar talker. It is possible that with the same hearing aids but a different task the measured benefit could have been different.

Results Point of Contact

• Title: Kendra Marks
• Organization: Northwestern University

kendra.marks@northwestern.edu

2069991423

Study Officials

• Pamela Souza, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: October 25, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)