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N/A N=118 Randomized Treatment

Smartphone Enabled Hearing Study

Hearing

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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