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Hearing Aid Education and Adaptation System

Interactive Technology for Hearing Aid Education and Acceptance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02839759
Enrollment
52
Registered
2016-07-21
Start date
2018-08-31
Completion date
2020-04-30
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Hearing loss, Presbycusis, Aging, Teleaudiology

Brief summary

This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.

Detailed description

HTM will develop the TELLYHealth (tm) system that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.

Interventions

OTHERTELLYHealth

Educational videos and questions.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Healthcare Technologies and Methods, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Speaks and reads English fluently * Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss * Will be fitted with one or two hearing aids at the time of enrollment * Owns a standard TV * Has Internet access at home * Has sufficient corrected vision to watch videos and read text on the TV and mobile device * No signs of dementia

Exclusion criteria

* Lives with person who has enrolled in the study

Design outcomes

Primary

MeasureTime frameDescription
Hearing Handicap Inventory for the Elderly (HHIE)8-12 weeksPre-post changes in the HHIE total scores

Secondary

MeasureTime frameDescription
Communication Scale for Older Adults (CSOA)8-12 weeksPre-post changes in the CSOA communication strategies & attitudes scores

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026