Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid

Not Applicable

Completed

• Conditions: Mild and Moderate Presbycusis
• Interventions: Device: Use of a personal sound amplifying device = TeoFirst

• Registration Number: NCT01815788
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid.

The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Study Start: 2013-04
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Wish to increase hearing
• Moral commitment to use the device
• Ability to understand the study
• Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
• Patient 60 years of age and older,
• No previous hearing aid

Exclusion Criteria

• Inability to use the device
• Previous use of a hearing aid
• local intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teo first	Use of a personal sound amplifying device = TeoFirst	* Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz) * Patient 60 years of age and older, * No previous hearing aid

Primary Outcome Measures

Name	Time	Method
Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst	7 to 15 days after the first use of Teofirst

Secondary Outcome Measures

Name	Time	Method
audiometric and mental tests	D7 to 15 and D 40	* Glasgow Hearing Aid Benefit Profile (GHABP); * Acceptability and use questionnaire; * ANL (Acceptable Noise Level) test; * Mini Mental State Examination; * Instrumental Activities of Daily Living (IADL)

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France