Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mild and Moderate Presbycusis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Use of a personal sound amplifying device = TeoFirst | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Teo first
- 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
- interventionNames
- Device: Use of a personal sound amplifying device = TeoFirst
Primary outcomes (1)
- measure
- Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst
- timeFrame
- 7 to 15 days after the first use of Teofirst
Secondary outcomes (1)
- measure
- audiometric and mental tests
- timeFrame
- D7 to 15 and D 40
- description
- * 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSacco G, Gonfrier S, Teboul B, Gahide I, Prate F, Demory-Zory M, Turpin JM, Vuagnoux C, Genovese P, Schneider S, Guerin O, Guevara N. Clinical evaluation of an over-the-counter hearing aid (TEO First(R)) in elderly patients suffering of mild to moderate hearing loss. BMC Geriatr. 2016 Jul 9;16:136. doi: 10.1186/s12877-016-0304-4. PMID 27392722