MedPath

Smartphone Enabled Hearing Study

Not Applicable
Completed
Conditions
Hearing
Registration Number
NCT05872035
Lead Sponsor
Apple Inc.
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
118
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
International Outcome Inventory for Hearing Aids (IOI-HA) Survey ResultsApproximately 18-31 days upon enrollment

The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

IQVIA

🇺🇸

Overland Park, Kansas, United States

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