Smartphone Enabled Hearing Study

NCT05872035 | Completed Results FDA Device

• 1 other identifier: 099-37012
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing

Outcome Measures

Primary Outcomes (1)

• International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results

  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.

  Approximately 18-31 days upon enrollment

Study Arms (2)

Self-Fit Settings

EXPERIMENTAL

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

Device: Apple Software

Pro-Fit Settings

ACTIVE COMPARATOR

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

Device: by Audiologist

Interventions

Apple Software DEVICE

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

Self-Fit Settings

by Audiologist DEVICE

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

Pro-Fit Settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apple Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (1)

IQVIA

Overland Park, Kansas, 66211, United States

Location

Results Point of Contact

• Title: Rajiv Kumar, MD
• Organization: Apple

htclinicalquestions@apple.com

8669055303

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 24, 2023
• Study Start: April 20, 2023
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)