Hearing Aid Education and Adaptation System

Healthcare Technologies and Methods

Status: Completed

Conditions: Hearing Loss

Treatments: Other: TELLYHealth

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02839759

HTM092016

R44AG045947 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

TELLYHealth Group

Experimental group

Description:

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.

Treatment:

Other: TELLYHealth

Standard of Care Group

No Intervention group

Description:

Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.