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.
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
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 group | Role | What they receive |
|---|---|---|
| AirPod Pro2 | Experimental | Not described Receives: Device: Over-the-Counter Hearing Aid; Device: Hearing aid, air conduction |
| Hearing Aid | Active comparator | Not 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.
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
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.
- First posted1 Jul 2025
- Study start11 Sep 2025
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study: Hearing Evaluation and Real-Ear Measurements of Apple AirPods Pro 2 vs. Phonak Hearing Aids
- ClinicalTrials.gov ID
- NCT07044518
- Acronym / sponsor ID
- 00005980
- Conditions
- Hearing Loss
- Keywords
- hearing loss, over-the-counter hearing aid, hearing aid, OTC hearing aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AirPod Pro2 | Experimental | Device: Over-the-Counter Hearing Aid, Device: Hearing aid, air conduction |
| Hearing Aid | Active comparator | Device: Over-the-Counter Hearing Aid, Device: Hearing aid, air conduction |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking,
- Normal otoscopy
- Mild to moderate hearing loss
Key exclusion criteria (3 listed)
- Non-English speaking,
- Active ear infection at time of appointment,
- Outside the normal range (score <71) on the XpressO Montreal Cognitive Assessment (MoCA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Over-the-Counter Hearing AidThis 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. | Device | AirPod Pro2, Hearing Aid |
| Hearing aid, air conductionThis 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. | Device | AirPod Pro2, Hearing Aid |
Primary outcome
Hearing evaluation
Time frame: From the beginning to the end of a single study visit lasting approximately 45 minutes
measure that evaluates hearing threshold at octave frequencies between 250 to 8000Hz; measured in dB HL.
Real Ear Measures
Time frame: From the beginning to the end of a single study visit lasting approximately 45 minutes
measures how much sound level (gain) a hearing aid is delivering at octave frequencies between 250 to 8000 Hz; measured in dB SPL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.