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Hearing LossNCT07044518

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

A study testing Over-the-Counter Hearing Aid and Hearing aid, air conduction in people with Hearing Loss, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Hearing Loss
What is being tested?
Over-the-Counter Hearing Aid and Hearing aid, air conduction
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
11 Sep 2025to 4 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Arizona Hearing Clinic

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Comparison Study: Hearing Evaluation and Real-Ear Measurements of Apple AirPods Pro 2 vs. Phonak Hearing Aids

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?
Read more

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
Read the 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
Being tested
Over-the-Counter Hearing Aid, Hearing aid, air conduction
Keywords
hearing loss, over-the-counter hearing aid, hearing aid, OTC hearing aid
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Over-the-Counter Hearing AidDevice

    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 conductionDevice

    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.

Study groups in NCT07044518
Study groupRoleWhat they receive
AirPod Pro2ExperimentalNot described
Receives: Device: Over-the-Counter Hearing Aid; Device: Hearing aid, air conduction
Hearing AidActive comparatorNot described
Receives: Device: Over-the-Counter Hearing Aid; Device: Hearing aid, air conduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hearing evaluation

    measure that evaluates hearing threshold at octave frequencies between 250 to 8000Hz; measured in dB HL.

    Measured: From the beginning to the end of a single study visit lasting approximately 45 minutes

  2. Real Ear Measures

    measures how much sound level (gain) a hearing aid is delivering at octave frequencies between 250 to 8000 Hz; measured in dB SPL.

    Measured: From the beginning to the end of a single study visit lasting approximately 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start11 Sep 2025
  3. Primary completion4 Dec 2025
  4. Study completion4 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07044518
Sponsor's protocol ID
00005980
Status last verified
Dec 2025
First submitted
23 Jun 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Over-the-Counter Hearing Aid and Hearing aid, air conduction in people with Hearing Loss, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing evaluation (time frame: From the beginning to the end of a single study visit lasting approximately 45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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