N/A
N=118
Smartphone Enabled Hearing Study
Hearing
Bottom Line
View on ClinicalTrials.gov: NCT05872035 ↗Enrolled (actual)
118
Serious AEs
0.9%
Results posted
Oct 2024
Primary outcome: Primary: International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results — 25.5; 26.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Apple Software (Device); by Audiologist (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Apple Inc.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results |
25.5; 26.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05872035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.