Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

• Conditions: Otosclerosis; Tympanic Membrane Perforation
• Interventions: Procedure: myringoplasty; Procedure: Stapes surgery

• Registration Number: NCT00222417
• Lead Sponsor: University Hospital of North Norway

Brief Summary

We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

Detailed Description

Consecutive patients 12 years or older due for myringoplasty or stapes surgery at the ENT-department, University hospital of Tromsø, in an approximate time span of one year, have been studied with the following audiometric investigations at the preoperative admission, 2, 6 and 12 months postoperatively: Transient otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, speech audiometry using spondaic recognition for air and bone-conduction. Results will be statistically analysed using the Statistical Package for the Social Sciences, with the unoperated ear (paired organ) serving as controls. The goal is to look at alternative methods for analysing the patients' preoperative hearing in order to increase the precision of clinical decision-making. The secondary goal is to elucidate the effects of middle ear surgery on the inner ear.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-21
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Tympanic membrane perforation without chronic secretion or cholesteatoma
• Suspected otosclerosis

Exclusion Criteria

• Below 12 years of age
• Patient not consenting to study
• Perioperative findings suggesting chronic otitis or cholesteatoma
• Patients not fluent in Norwegian or unable to cooperate in audiometry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myringoplasty	myringoplasty	Patients subject to myringoplasty for tympanic membrane perforations.
Otosclerosis	Stapes surgery	Patients subject to stapes surgery

Primary Outcome Measures

Name	Time	Method
Post-operative hearing threshold level	1 year	Pure tone audiometry, speech audiometry, otoacoustic emissions

Trial Locations

Locations (1)

ENT-department, University Hospital of Tromsø; 🇳🇴 Tromsø, Troms, Norway