Hearing Aid Education and Adaptation System

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Other: TELLYHealth

• Registration Number: NCT02839759
• Lead Sponsor: Healthcare Technologies and Methods, LLC

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.

Study Timeline

• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Study Start: 2018-08-31
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TELLYHealth Group	TELLYHealth	Subjects will receive the standard of care in hearing aid education and the TELLYHealth intervention for use over an 8 to12-week period and will be followed by their audiologist for 8 to 12 weeks.

Primary Outcome Measures

Name	Time	Method
Hearing Handicap Inventory for the Elderly (HHIE)	8-12 weeks	Pre-post changes in the HHIE total scores

Secondary Outcome Measures

Name	Time	Method
Communication Scale for Older Adults (CSOA)	8-12 weeks	Pre-post changes in the CSOA communication strategies \& attitudes scores

Trial Locations

Locations (2)

Clear Sound Audiology; 🇺🇸 Gainesville, Florida, United States

Potomac Audiology; 🇺🇸 Rockville, Maryland, United States