Skip to main content
OpenTrials
Completed

NCT Number: NCT02839759

Hearing Aid Education and Adaptation System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clear Sound Audiology, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TELLYHealth

Other

Educational videos and questions.

Primary outcomes

  1. Hearing Handicap Inventory for the Elderly (HHIE)

    Time frame: 8-12 weeks

    Pre-post changes in the HHIE total scores

Secondary outcomes

  1. Communication Scale for Older Adults (CSOA)

    Time frame: 8-12 weeks

    Pre-post changes in the CSOA communication strategies & attitudes scores

Sponsors and collaborators

Lead sponsor

Healthcare Technologies and Methods, LLC

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Interactive Technology for Hearing Aid Education and Acceptance

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2016
Registry last updated
May 14, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.