Smartphone Enabled Hearing Study

Apple

Status: Completed

Conditions: Hearing

Treatments: Device: Apple Software; Device: by Audiologist

Study type: Interventional

Funder types: Industry

Identifiers

NCT05872035

099-37012

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

118 participants in 2 patient groups

Self-Fit Settings

Experimental group

Description:

Amplification settings established by algorithm and further adjusted by participants per their preference

Treatment:

Device: Apple Software

Pro-Fit Settings

Active Comparator group

Description:

Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice

Treatment:

Device: by Audiologist