Validating a Self-fitting Hearing Aid

NCT05246904 | Completed

• 1 other identifier: STUDY00015143
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.

Conditions

Hearing and Vision Loss

Keywords

hearing aids, self-fitting

Outcome Measures

Primary Outcomes (2)

• Abbreviated profile of hearing aid benefit

  Survey of subjective benefit

  2-3 weeks

• Speech in noise test, AZ Bio sentences

  Sentence recognition test in background noise

  Immediately after fitting

Secondary Outcomes (1)

• Subjective sound quality rating

  2-3 weeks

Study Arms (2)

audiologist arm

ACTIVE COMPARATOR

A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.

Other: Fitting algorithm

self-fit arm

ACTIVE COMPARATOR

Participants will follow manufacturer's printed instructions to complete the self-hearing test using the hearing aids and a provided app to program their hearing aids.

Other: Fitting algorithm

Interventions

Fitting algorithm OTHER

The best fitting algorithm will be selected by the audiologist (arm 1) or software.

audiologist arm; self-fit arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate hearing loss ability to follow written directions,

You may not qualify if:

• inability to use software during first visit

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Deaf-Blind Disorders

Condition Hierarchy (Ancestors)

Deafness; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Vision Disorders; Eye Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned and will not know which fit is first.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to arm 1 (audiologist fit) or arm 2 (self fit) first. After 2-3 weeks they will be tested and then assigned to the opposite arm.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 18, 2022
• Study Start: March 17, 2022
• Primary Completion: November 1, 2022
• Study Completion: February 28, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)