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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

  • Device: Use of a personal sound amplifying device = TeoFirst

Arms, Groups and Cohorts

  • Experimental: Teo first
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • audiometric and mental tests
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas GUEVARA, PH, Principal Investigator, Centre Hospitalier Universitaire de Nice

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