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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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01815788
Acronym
TEO FIRST
Enrollment
31
Registered
2013-03-21
Start date
2013-04-30
Completion date
2014-06-30
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild and Moderate Presbycusis

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.

Interventions

DEVICEUse of a personal sound amplifying device = TeoFirst

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst7 to 15 days after the first use of Teofirst

Secondary

MeasureTime frameDescription
audiometric and mental testsD7 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026