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

NCT07738549 | Not Yet Recruiting

• 2 other identifiers: AOI 2023 PUECHMAILLE2025-A01827-42
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surdity; the Audiological and Electrophysiological Profile of Hidden Hearing Loss

Outcome Measures

Primary Outcomes (7)

• Pure-tone audiometry (air and bone conduction)

  5 minutes

• Speech audiometry in quiet

  10 minutes

• Framatrix® test (Interacoustics)

  15 min

• Transient-evoked otoacoustic emissions (TEOAEs)

  2 min

• Distortion product otoacoustic emissions (DPOAEs)

  5 minutes

• Electrocochleography

  10 minutes

• Auditory brainstem responses (ABR)

  10 min

Study Arms (2)

Control group

NO INTERVENTION

Patients group

EXPERIMENTAL

Diagnostic Test: Audiometric tests

Interventions

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.

Patients group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathilde PUECHMAILLE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-06

Locations

FR (1)