NCT07044518

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

June 23, 2025

Last Update Submit

December 16, 2025

Conditions

Hearing Loss

Keywords

hearing lossover-the-counter hearing aidhearing aidOTC hearing aid

Outcome Measures

Primary Outcomes (2)

  • Hearing evaluation

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

    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.

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

Study Arms (2)

AirPod Pro2

EXPERIMENTAL
Device: Over-the-Counter Hearing AidDevice: Hearing aid, air conduction

Hearing Aid

ACTIVE COMPARATOR
Device: Over-the-Counter Hearing AidDevice: Hearing aid, air conduction

Interventions

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.

AirPod Pro2Hearing Aid
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.

AirPod Pro2Hearing Aid

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Arizona Hearing Clinic

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 1, 2025

Study Start

September 11, 2025

Primary Completion

December 4, 2025

Study Completion

December 4, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)