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Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane

Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07431125
Enrollment
100
Registered
2026-02-24
Start date
2026-01-01
Completion date
2026-08-01
Last updated
2026-07-24

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

Conditions

Conductive Hearing Loss, Unilateral

Keywords

Otoscelrosis, Exploration Tympanotomy, stapedectomy, tympanic membrane, conductive hearing loss

Brief summary

Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. However, although otosclerosis is traditionally regarded as a bilateral disease, clinical presentation may be unilateral due to asymmetric disease progression or subclinical contralateral involvement. Other etiologies, including congenital ossicular anomalies, ossicular discontinuity, tympanosclerosis without tympanic membrane involvement, or oval window abnormalities, may mimic otosclerosis both clinically and audiologically. Consequently, exploratory tympanotomy remains the gold standard for definitive diagnosis, allowing direct assessment of ossicular chain mobility and confirmation of stapes fixation. Correlating preoperative clinical suspicion with intraoperative findings is therefore essential to better define the true causes of unilateral conductive hearing loss with an intact tympanic membrane.

Interventions

PROCEDUREExporlation Tympanotomy

exploration tympanotomy of the middle ear and ossicles to diagnose or detect actual causes of conductive hearing loss and correct it according to the cause

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* unilateral conductive hearing loss or mixed HL with intact Tympanic Membrane * Average Airborne Gap Above 20 decibels

Exclusion criteria

* Sensorineural hearing loss * Chronic otitis media * TM perforation * Previous ear surgery

Design outcomes

Primary

MeasureTime frameDescription
Improvement of the Airborne ( conductive ) gapup to three months SurgeryDifference between preoperative and postoperative Average Airbone gap in dicebel

Countries

Egypt

Contacts

CONTACTtarek Mansour, head of research committe
ethicscommitt0ee@azhar.edu.eg+0201006237731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026