Smartphone Enabled Hearing Study
- 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
- 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
- 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
Name Time Method International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results Approximately 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
Name Time Method
Trial Locations
- Locations (1)
IQVIA
🇺🇸Overland Park, Kansas, United States