Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07738549

Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.

This study aims to investigate the underlying mechanisms of speech-in-noise difficulties in patients with normal conventional pure-tone and speech audiometry. Participants presenting with complaints of impaired speech understanding in noisy environments will undergo a comprehensive audiological assessment, including extended high-frequency audiometry, electrocochleography (EcoG), distortion product otoacoustic emissions (DPOAEs), auditory brainstem responses (ABR), and central auditory processing evaluation. The study seeks to identify cochlear, neural, and central auditory abnormalities that may contribute to hidden hearing loss and improve its clinical characterization.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Surdity Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms the Audiological and Electrophysiological Profile of Hidden Hearing Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Adult patients (age > 18 years). Patients affiliated with a social security/health insurance system. Patients consulting the ENT department for hearing difficulties despite normal conventional pure-tone and speech audiometry performed in quiet.

Patients whose native language is French. Patients who have received oral and written information about the study and have provided free and informed consent.

Normal otoscopic examination:

No external auditory canal obstruction. No history of middle ear surgery (except childhood tympanostomy tube placement).

Presence of a translucent tympanic membrane in at least one quadrant, with no tympanic membrane perforation.

No signs of active otitis infection. No signs of cholesteatoma. Well-ventilated middle ear cavity confirmed by conventional tympanometry at 226 Hz.

  • Inclusion criteria for the control group:

Adult patients aged between 18 and 25 years. Patients seen during an ENT consultation at Clermont-Ferrand University Hospital, without any hearing complaints.

Patients with normal conventional pure-tone audiometry performed in quiet, defined as hearing thresholds between 0 and 20 dB HL across frequencies from 0.25 to 8 kHz, according to BIAP 2017 criteria.

No selection bias is expected, as normal hearing is defined as hearing thresholds between 0 and 20 dB HL (BIAP 2017). This age range was selected because it provides the highest likelihood of including individuals with normal auditory function.

-Exclusion criteria :

Patients under legal guardianship, curatorship, judicial protection, or deprived of liberty.

Pregnant or breastfeeding women. History of language disorders.

Abnormal pure-tone audiometry in quiet, defined as:

Mean pure-tone hearing loss > 20 dB HL, or At least one frequency threshold > 20 dB HL.

Abnormal speech audiometry, defined as:

Speech reception threshold on Lafon disyllabic word lists (male voice) > 20 dB HL, and/or Maximum speech intelligibility score of 100% obtained at a level > 40 dB HL. Refusal to participate in the study.

Treatment and study plan

Audiometric tests

Diagnostic Test

Audiological and electrophysiological tests will be performed in patients presenting with complaints of hearing difficulties in noisy environments despite normal pure-tone and speech audiometry in quiet.

Primary outcomes

  1. Pure-tone audiometry (air and bone conduction)

    Time frame: 5 minutes

  2. Speech audiometry in quiet

    Time frame: 10 minutes

  3. Framatrix® test (Interacoustics)

    Time frame: 15 min

  4. Transient-evoked otoacoustic emissions (TEOAEs)

    Time frame: 2 min

  5. Distortion product otoacoustic emissions (DPOAEs)

    Time frame: 5 minutes

  6. Electrocochleography

    Time frame: 10 minutes

  7. Auditory brainstem responses (ABR)

    Time frame: 10 min

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: SURDICACH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.