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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 (TEO FIRST)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Mild and Moderate Presbycusis

Treatments

Device: Use of a personal sound amplifying device = TeoFirst

Study type

Interventional

Funder types

Other

Identifiers

NCT01815788
12-PP-17

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

60 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Teo first
Experimental group
Description:
* 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
Treatment:
Device: Use of a personal sound amplifying device = TeoFirst

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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