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Completed

NCT Number: NCT01815788

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

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.

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Key information

Conditions

Mild and Moderate Presbycusis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Use of a personal sound amplifying device = TeoFirst

Device

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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.

Acronym: TEO FIRST

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2013
Registry last updated
Nov 13, 2023

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.

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