Surgical correlation for one-sided conductive hearing loss with an intact eardrum
Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane
This test uses exploratory tympanotomy to see if the exact cause of one-sided conductive hearing loss with a normal eardrum can be found.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Asyut, Asyut Governorate) |
| Trial ID | NCT07431125 on ClinicalTrials.gov |
What this trial studies
Patients with one-sided conductive or mixed hearing loss and an intact tympanic membrane who have an average air–bone gap over 20 dB will undergo exploratory tympanotomy. Surgeons will document intraoperative findings—such as stapes fixation from otosclerosis, ossicular discontinuity, congenital ossicular anomalies, or tympanosclerosis—and compare them with preoperative clinical and audiologic impressions. People with sensorineural hearing loss, chronic otitis media, tympanic membrane perforation, or prior ear surgery are excluded to focus on true conductive causes. The work is performed at Al-Azhar University Hospital in Asyut and relies on direct surgical inspection for definitive diagnosis.
Who should consider this trial
Good fit: Ideal candidates are people with unilateral conductive or mixed hearing loss, an intact tympanic membrane, an average air–bone gap above 20 dB, and no chronic ear disease or prior ear surgery.
Not a fit: Patients with sensorineural hearing loss, chronic otitis media, tympanic membrane perforation, or previous ear surgery are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could give patients a definitive diagnosis that enables more targeted surgery and improved hearing results.
How similar studies have performed: Exploratory tympanotomy is an established diagnostic gold standard for distinguishing otosclerosis from other ossicular problems, so the approach aligns with prior clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Asyut, Asyut Governorate
- Alazhar university Hopital in Assiut — Asyut, Asyut Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: tarek Mansour, head of research committe
- Email: ethicscommitt0ee@azhar.edu.eg
- Phone: +0201006237731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.