The Clinical Application of Apple AirPods Pro 2 vs. Hearing Aids

NCT ID: NCT07044518

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2025-12-04

Brief Summary

The goal of this clinical trial is to learn whether the Apple AirPods Pro 2 can accurately test hearing and provide helpful amplification, like a traditional hearing aid, in adults with hearing loss. The main questions it aims to answer are:

• Can the AirPods Pro 2 hearing test give similar results to a standard hearing test done in a sound booth by an audiologist?
• Can the AirPods Pro 2 provide amplification (make sounds louder) in a way that matches what a traditional hearing aid would provide?

Researchers will compare the AirPods Pro 2 results to standard hearing tests and hearing aid fittings to see if they perform in a similar way.

Participants will:

• Take a standard hearing test in a sound booth
• Use the Apple Hearing Test with AirPods Pro 2
• Have the loudness of the AirPods and a traditional hearing aid measured and compared using special equipment

Detailed Description

Hearing loss is becoming one of the most prevalent, yet undertreated health conditions in the United States. A staggering 5% of the world's population - or 430 million people - require rehabilitation to address their disabling hearing loss (including 34 million children), and it is estimated that by 2050, 700 million people - or 1 in every 10 people - will have disabling hearing loss (WHO, 2024). In the United States alone, the National Institute on Deafness and Other Communication Disorders predicts that approximately 15%, or 37.5 million, of American adults ages 18 years and over have some degree of hearing loss. The severity of hearing loss increases with age, affecting about one in three people between the ages of 65 and 74 years, and nearly half of those older than 75 years (NIDCD, 2023). Although hearing loss is a major health issue, it is estimated that the utilization rate of hearing aids is about 15% (Nassiri et al., 2021).

A major factor for this low utilization rate of hearing aids is the difficulty in accessibility of services for certain individuals, primarily those with financial constraints or those who live in rural areas with fewer audiologists (Carr & Kihm, 2022). Furthermore, insurance typically provides little to no coverage for hearing aids despite it being the most efficacious treatment. According to Arnold et al. (2017), Medicaid only provides hearing aid coverage in 28 states with substantial coverage variability between individual states. One way this issue has been addressed is through the development of over-the-counter hearing aids (OTCs), which can be purchased online or at a retail center without a requirement for an audiologist. The U.S. Food and Drug Administration approved the use of OTCs in 2022 for consumers 18 years or older with a perceived mild to moderate hearing loss (Stephenson, 2022). A retrospective survey study by Manchaiah et al. (2023) found that 84% of respondents expressed discomfort with OTCs and that the majority of respondents had concerns for safety, counseling, and audiological care. Although there has been some hesitation toward the use of OTCs from practicing audiologists, a study performed by Swanepoel et al. (2023) suggests that there is no significant difference in mostly objective, but also subjective, outcomes when comparing traditional hearing aids provided by hearing healthcare professionals and over-the-counter options.

A multinational tech corporation, Apple, has developed a Hearing Test Feature (HTF), an over-the-counter air-conduction hearing assessment for use with the Apple AirPods Pro 2 devices using a compatible iPhone or iPad (iOS 18.1 or higher). With their update for the AirPods Pro 2 (AP2), an individual can self-administer a hearing evaluation. The device would then use their test results, or audiogram, to set the gain in the individual's AirPods for daily use as an OTC hearing aid, using the Hearing Aid Feature (HAF). This new feature has the potential to allow users to access hearing amplification without purchasing higher-cost devices or seeing an audiologist.

Currently there is a critical gap in research that evaluates Apple's new Hearing Health Features. This project aims to research the validity of Apple's HTF and HAF by comparing results to a conventional audiologic evaluation and Phonak hearing aids.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AirPod Pro2

Group Type: EXPERIMENTAL

Over-the-Counter Hearing Aid

Intervention Type: DEVICE

This intervention involves a self-fit, over-the-counter (OTC) hearing aid that is set up by the user with limited to no help from a hearing professional. Amplification is personalized through an app-based hearing test on a smartphone. The device is used during a single study visit (90 minutes) to assess hearing and provide amplification.

Hearing aid, air conduction

Intervention Type: DEVICE

This intervention uses a prescription hearing aid that is programmed and fitted based on results from a standard hearing test. The device is also used during a single study visit (90 min) for comparison purposes.

Hearing Aid

Group Type: ACTIVE_COMPARATOR

Over-the-Counter Hearing Aid

Intervention Type: DEVICE

This intervention involves a self-fit, over-the-counter (OTC) hearing aid that is set up by the user with limited to no help from a hearing professional. Amplification is personalized through an app-based hearing test on a smartphone. The device is used during a single study visit (90 minutes) to assess hearing and provide amplification.

Hearing aid, air conduction

Intervention Type: DEVICE

This intervention uses a prescription hearing aid that is programmed and fitted based on results from a standard hearing test. The device is also used during a single study visit (90 min) for comparison purposes.

Interventions

Over-the-Counter Hearing Aid

This intervention involves a self-fit, over-the-counter (OTC) hearing aid that is set up by the user with limited to no help from a hearing professional. Amplification is personalized through an app-based hearing test on a smartphone. The device is used during a single study visit (90 minutes) to assess hearing and provide amplification.

Intervention Type: DEVICE

Hearing aid, air conduction

This intervention uses a prescription hearing aid that is programmed and fitted based on results from a standard hearing test. The device is also used during a single study visit (90 min) for comparison purposes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• English speaking,
• Normal otoscopy
• Mild to moderate hearing loss

Exclusion Criteria

• Non-English speaking,
• Active ear infection at time of appointment,
• Outside the normal range (score <71) on the XpressO Montreal Cognitive Assessment (MoCA)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Arizona Hearing Clinic

Tucson, Arizona, United States

Countries

United States

Other Identifiers

00005980

Identifier Type: -

Identifier Source: org_study_id