NCT04172766

Brief Summary

The Apple Hearing Study is a partnership between the University of Michigan and Apple to study sound exposure and its impact on hearing health. This groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. The investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. US residents who own an iPhone, download the Apple Research app and consent to participate will be randomly assigned to two groups, one with a "Basic" user interface in the Research app, and one with an "Advanced" user interface. Users in the "Advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. The study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. This information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the US and globally.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300,000

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress66%
Nov 2019Dec 2029

First Submitted

Initial submission to the registry

November 13, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

9.8 years

First QC Date

November 13, 2019

Last Update Submit

March 17, 2026

Conditions

TinnitusHearing Loss, Noise-InducedHearing Loss

Keywords

Hearing LossNoise ExposureNoise Induced Hearing LossListening VolumeEnvironmental NoiseMusicAudiometrySpeech-in-NoiseHearing AbilityHeadphonesHeadphone audio levelAmbient noiseOccupational noiseHeart rateTinnitus

Outcome Measures

Primary Outcomes (14)

  • Headphone audio level patterns

    For the entire cohort over various timeframes

    From enrollment to the end of followup at 10 years

  • Difference in Headphone Audio Level patterns

    This will include assessment of sound pressure level and time at baseline and over the duration of the study.

    From enrollment to the end of followup at 10 years

  • Association between Headphone Audio Level patterns and Pure Tone Audiometry

    Analysis will occur for each tested frequency (dB HL at 125 Hz, 250 Hz, 500 Hz, 1 kHz, 2 kHz, 4kHz, and 8 kHz assessed for both ears) for both ears at baseline and over the duration of the study.

    From enrollment to the end of followup at 10 years

  • Association between Headphone Audio Level patterns and Speech in Noise

    Analysis will assess the speech recognition threshold and it's relationships with HAL at baseline and over the duration of the study

    From enrollment to the end of followup at 10 years

  • Association between Headphone Audio Level patterns and tinnitus matching

    At baseline and over the duration of the study

    From enrollment to the end of followup at 10 years

  • Association between general health and individual characteristics and sound levels and/or audiometry tasks

    Headphone Audio Levels will be assessed as the sound level and the audiometry tasks assessed will be Pure Tone Audiometry, Speech in Noise, and tinnitus matching

    From enrollment to the end of followup after 10 years

  • Change from baseline to final audiometry

    Including both Pure Tone Audiometry and Speech in Noise

    From enrollment to the end of followup after 10 years

  • Change from baseline in abbreviated Pure Tone Audiometry following high headphone audio level notification

    This comparison will occur for two frequencies (1 kHz and 4 kHz for both ears) within 24 hours of acute loud Headphone Audio Level exposure (LEQ equivalent to \>97 dBA for \>30 minutes)

    From enrollment to the end of followup after 10 years

  • Headphone Audio Level association with baseline survey questions

    This will includes questions about typical headphone us, typical environmental exposures, and hearing ability.

    From enrollment to the end of followup after 10 years

  • Baseline Audiometry association with baseline survey questions

    Baseline Audiometry includes both Pure Tone Audiometry and Speech in Noise. Survey questions include those regarding typical headphone use, typical environmental exposures, and hearing ability.

    From enrollment to the end of followup after 10 years

  • Final Audiometry association with end-of-study survey questions

    Final Audiometry includes Pure Tone Audiometry and Speech in Noise. The end-of-study survey questions include typical headphone use, typical environmental exposures, and hearing ability.

    At the end of followup after 10 years

  • Change in survey questions

    Survey questions regarding exposure changes over the course of the study

    From enrollment to the end of followup after 10 years

  • Association between hearing ability and changes in hearing health and related health conditions

    Hearing ability is evaluated both as perceived and evaluated. Changes in hearing health include audiometry and tinnitus. Related health conditions include items such as cognition, sleep, mental health, activity, mobility, and more.

    From enrollment to the end of followup after 10 years

  • Descriptive assessment of participant use and experience

    Experience with hearing related tools and device

    From enrollment to the end of followup after 10 years

Secondary Outcomes (10)

  • Difference in Environmental Sound Level Patterns

    From enrollment to the end of followup after 10 years

  • Association between Headphone Audio Levels and Environmental Sound Level patterns

    From enrollment to the end of followup after 10 years

  • Association between Environmental Sound Level patterns and Pure Tone Audiometry.

    From enrollment to the end of followup after 10 years

  • Association between Environmental Sound Level patterns and Speech in Noise

    From enrollment to the end of followup after 10 years

  • Association between Environmental Sound Level patterns and tinnitus matching task

    From enrollment to the end of followup after 10 years

  • +5 more secondary outcomes

Other Outcomes (2)

  • Impact of hearing ability on other related aspects of health

    From enrollment to the end of followup after 10 years

  • Assess novel versions of hearing assessments

    From enrollment to the end of followup after 10 years

Study Arms (1)

Cohort

Participants will be asked to read and sign the study ICF within the app if they agree and are willing to participate. After providing informed consent to participate, participants will be directed to select which data they want to share from the Health App via HealthKit and SensorKit to the Research app. All Research app users are asked to complete contact information and demographic questions that may be common across multiple Research app studies, such as age, race, sex, location of residence, and socioeconomic status. Participants will be asked to complete surveys approximately every other month for a total of about 1.5 hours over the entire year. Participants will be asked to complete three types of hearing tests 2-6 times per year; Interactive Tinnitus Tasks, Pure Tone Audiometry, and Speech in Noise. Participants will also be requested to complete brief on-demand surveys following high sound level measurements from headphones or the watch, at most monthly.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults age 18 or older that live in the U.S. or U.S. territories and have iPhone with the Research app installed.

You may qualify if:

  • Age ≥ 18 years at time of eligibility screening, ascertained from self-reported date of birth. Potential subjects in the states of Alabama and Nebraska must be 19 or older (legal age of consent in these states), and 21 and older for any subjects in Puerto Rico.
  • Live in the United States of America at time of eligibility screening, ascertained from self-report.
  • Proficient in written and spoken English, defined by self-report.
  • Participants must NOT share their iCloud account, iPhone or other devices such as Apple Watch with anyone else as this would make it challenging for researchers to use their information.
  • Possession of the following, ascertained from automatic hardware/software/device pairing check:
  • iPhone with iOS versions capable of supporting the Research app used to complete screening eligibility.
  • Optional: Apple Watch (any model) paired with iPhone; an Apple Watch Series 4 or later is required to share environmental sound levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Public Health

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • Smith LM, Wang L, Mazur K, Carchia M, DePalma G, Azimi R, Mravca S, and Neitzel RL. Impacts of COVID-19-related social distancing measures on personal environmental sound exposures. Environmental Research Letters. Oct 2020. 15.10: 104094. https://iopscience.iop.org/article/10.1088/1748-9326/abb494

    RESULT

  • Neitzel RL, Smith L, Wang L, Green G, Block J, Carchia M, Mazur K, DePalma G, Azimi R, Villanueva B. Toward a better understanding of nonoccupational sound exposures and associated health impacts: Methods of the Apple Hearing Study. J Acoust Soc Am. 2022 Mar;151(3):1476. doi: 10.1121/10.0009620.

    PMID: 35364926RESULT

Related Links

MeSH Terms

Conditions

Hearing Loss, Noise-InducedHearing LossTinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Richard L Neitzel, PhD, MS, CIH

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Lauren M Smith, MS, MPH

    University of Michigan

    STUDY DIRECTOR

  • Joyce M Daniels, MA

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Environmental Health Sciences and Associate Professor of Global Public Health

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 21, 2019

Study Start

November 14, 2019

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

N/A - no plan to share

Locations

US(1)