Smartphone Enabled Hearing Study

NCT ID: NCT05872035

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-08-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-Fit Settings

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

Group Type: EXPERIMENTAL

Apple Software

Intervention Type: DEVICE

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

Pro-Fit Settings

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

Group Type: ACTIVE_COMPARATOR

by Audiologist

Intervention Type: DEVICE

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

Interventions

Apple Software

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

Intervention Type: DEVICE

by Audiologist

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Apple Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IQVIA

Overland Park, Kansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

099-37012

Identifier Type: -

Identifier Source: org_study_id