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NCT04048460 · ClinicalTrials.gov registry record · NA

Assessment of e-Audiology for Providing Clinical Services and Support

A NA study, sponsored by University of South Florida.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT04048460: Completed NA study, sponsored by University of South Florida.

NCT04048460 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04048460, a NA study, has completed, sponsored by University of South Florida.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

Technological advances in hearing aids and telecommunications, including the widespread availability of telehealth (referred to in this proposal as "e-Audiology") applications, have the potential to expand both access and affordability of hearing aids for those with age-related hearing loss (ARHL). E-Audiology is used by clinicians in a variety of settings, including private practice, university clinics, and the Veterans Administration. The American Speech-Language-Hearing Association recently updated the Scope of Practice guidelines for audiology to include telehealth as "an alternative method of service delivery that en-compasses both diagnostics and intervention services.", including all aspects of hearing aid selection, fitting, and follow-up counseling and rehabilitation. However, given the paucity of evidence of comparative efficacy between office-based service delivery and e-Audiology in real-world settings, patients and relevant stakeholders are faced with a major decisional dilemma when determining which mode of service delivery would be optimal for addressing the needs, preferences, and lifestyles of those with ARHL. Thus, the purpose of this study is to determine the benefits, drawbacks, and patient satisfaction associated with e-Audiology delivery of hearing aid fitting, services, and supports for older adults with mild to moderate ARHL. We plan to use data collected in this pilot study for a future R01 submission to the NIH.

Primary Outcome

The Hearing Handicap Inventory for the Elderly Screening (HHIE-S) (Ventry and Weinstein 1982, Newman and Weinstein 1988) will be used to measure self-reported hearing difficulties. The Hearing Handicap Inventory scale is reported as an average across all participants and has a minimum value of 0 and a maximum value of 40. Higher scores indicate more perceived social and emotional difficulty due to an individuals hearing loss. Change in HHIE scores were calculated based on the change from basel

Interventions

  • DEVICE Delivery of hearing healthcare through eAudiology application

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-08-15
Est. Completion 2020-04-15
Phase NA
University of South Florida

252 total trials

What the finished NCT04048460 record still lists

NCT04048460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Delivery of hearing healthcare through eAudiology application is the first listed.

NCT04048460 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04048460 about?

NCT04048460 is a clinical study titled "Assessment of e-Audiology for Providing Clinical Services and Support". Technological advances in hearing aids and telecommunications, including the widespread availability of telehealth (referred to in this proposal as "e-Audiology") applications, have the potential to expand both access and affordability of hearing aids for those with age-related hearing loss (ARHL). ...

What is the current status of trial NCT04048460?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-08-15. Estimated completion is 2020-04-15.

What interventions are being tested in trial NCT04048460?

The interventions under investigation include: Delivery of hearing healthcare through eAudiology application (DEVICE).

Who is sponsoring clinical trial NCT04048460?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04048460's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04048460, the US trial registry maintained by the National Library of Medicine. NCT04048460 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.