NCT05855005

Direct-to-Consumer Hearing Aids and Listening Effort

Investigation of Direct-to-consumer Hearing Aids on Conversation Efficiency and Listening Effort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	DTC Hearing Aids	DTC hearing aid programmed to the individual participant.

Timeline

• Start date: 2022-10-25
• Primary completion: 2023-12-01
• Completion: 2023-12-30
• First posted: 2023-05-11
• Last updated: 2024-05-29
• Results posted: 2024-05-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study