Smartphone Enabled Hearing Study

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.

Study Overview

• Status: Completed
• Conditions: Hearing
• Intervention / Treatment: Device: Apple Software; Device: by Audiologist

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • IQVIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Fit Settings; Amplification settings established by algorithm and further adjusted by participants per their preference	Device: Apple Software; Amplification settings established by algorithm and further adjusted by participants per their preference
Active Comparator: Pro-Fit Settings; Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice	Device: by Audiologist; Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: IQVIA Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): August 17, 2023
• Study Completion (Actual): August 17, 2023

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 099-37012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No