Smartphone Enabled Hearing Study

Completed · Not applicable

Conditions studied: Hearing

In brief

Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.

Key facts

Study ID

NCT05872035

Run by

Apple Inc.

People needed

118

Starts

2023-04-20

Expected to finish

2023-08-17

Last updated by the study team

2024-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years
• Proficient in written and spoken English, defined by self-report
• Mild- to moderate- hearing loss as measured by pure tone audiometry (PTA) reference test, or self-report of perceived hearing loss and 15-25 dB HL (by 4PTA)
• Participants have access to stable internet connection

You may not qualify if…

• Ear anatomy non-conducive to comfortable wear of headphone
• Active ear disease
• Cerumen impaction that cannot be removed
• Sudden loss of hearing (in the preceding 90 days), defined by self-report
• Self Report of loud environmental sound exposure (e.g., concert; construction site; fireworks) without hearing protection within 72 hours of reference PTA assessed at Clinic Visit 1
• Tinnitus that impacts one's daily life, defined by self-report
• Use of cochlear implants
• Self-reported issues with small or confined spaces such as a single-person enclosed booth, and/or claustrophobia
• Health technology, fitness, media outlet employees (or spouse of employees), or employees of CRO/sites contracted to execute this study
• User noted preference to not wear headphone consistently, or charge headphone and smartphone consistently, during field-use
• Hearing loss >60 dB HL at 0.25-3kHz and >65 dB HL at 4kHz in either ear; assessed during PTA
• Hearing loss that requires electroacoustic settings which are not acoustically stable in the participant's ear per audiologist judgement
• Current regular use of hearing aids
• Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
• Active treatment, or treatment in the past 6 months, with parenteral aminoglycoside antibiotics
• In the Investigator's opinion, unable to adhere to study procedures

Where it is running

• IQVIA — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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