Apple Hearing Study (AHS)

Apple

Status: Enrolling

Conditions: Hearing Loss, Noise-Induced; Hearing Loss; Tinnitus

Treatments: Behavioral: Advanced

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04172766

HUM00167885 (Other Identifier)

Pro00037864

Details and patient eligibility

About

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.

Enrollment: 300,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Trial design

300,000 participants in 1 patient group

Cohort

Description:

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.