Distortion Product After Stapedotomy Surgery

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Abstract

This study aims at capturing for the first time at which frequencies and sound intensities hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Description

If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being normally mobile, a conductive hearing loss results. This conductive hearing loss is usually compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from the incus to the footplate of the removed stapes.

After surgery subjects sometimes state that the quality of sound is suboptimal, even though their hearing ability has improved significantly. Some subjects subjectively hear distorted sounds, which often disappear several weeks after surgery.

This study aims at capturing for the first time at which frequencies and sound intensities these distortions are perceived. Additionally, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Dates

Last Verified:	09/30/2016
First Submitted:	09/09/2014
Estimated Enrollment Submitted:	09/16/2014
First Posted:	09/18/2014
Last Update Submitted:	10/27/2016
Last Update Posted:	10/30/2016
Actual Study Start Date:	08/31/2014
Estimated Primary Completion Date:	04/30/2016
Estimated Study Completion Date:	04/30/2016

Condition or disease

Distorted Sound Perception

Phase

Arm Groups

Arm	Intervention/treatment
Control group No indication for stapedotomy
Distortion positive Subjects after stapedotomy perceiving sound distortions
Distortion negative Subjects after stapedotomy not perceiving sound distortions.

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Sampling method	Non-Probability Sample
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: - indication for stapedotomy - written consent given Exclusion Criteria: - not mentally able to give written consent

Outcome

Primary Outcome Measures

1. Change of distorted sound perception after stapedotomy surgery [7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery]

A psychoacoustic audiometric tests is performed; subjects are asked to press a button if the sound they hear is distorted, and this is tested at different frequencies and different level of loudness.

Secondary Outcome Measures

1. Questionnaire on quality of hearing after Stapedotomy (APOSE) [7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery]