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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07738549
Acronym
SURDICACH
Enrollment
80
Registered
2026-07-31
Start date
2026-07-01
Completion date
2027-07-01
Last updated
2026-07-31

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

Conditions

Surdity, the Audiological and Electrophysiological Profile of Hidden Hearing Loss

Brief summary

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.

Interventions

DIAGNOSTIC_TESTAudiometric tests

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Pure-tone audiometry (air and bone conduction)5 minutes
Speech audiometry in quiet10 minutes
Framatrix® test (Interacoustics)15 min
Transient-evoked otoacoustic emissions (TEOAEs)2 min
Distortion product otoacoustic emissions (DPOAEs)5 minutes
Electrocochleography10 minutes
Auditory brainstem responses (ABR)10 min

Countries

France

Contacts

CONTACTLise Laclautre
promo_interne_drci@chu-clermontferrand.fr+33473754963
PRINCIPAL_INVESTIGATORMathilde PUECHMAILLE

University Hospital, Clermont-Ferrand

Outcome results

None listed

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