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OpenTrials
Completed

NCT Number: NCT05872035

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IQVIA

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apple Software

Device

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

by Audiologist

Device

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

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Apple Inc.

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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