Distortion Product After Stapedotomy Surgery

Subjektiv Verzerrter Höreindruck Nach Stapedotomie

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.

Study Overview

• Status: Completed
• Conditions: Distorted Sound Perception

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Control group: Healthy volunteers are recruited by flyers that are displayed in the waiting zones of the ENT clinic.

Subjects with stapedotomy: Patients are being asked by the examining MD as soon as the indication for stapedotomy is proven.

Description

Inclusion Criteria:

• indication for stapedotomy
• written consent given

Exclusion Criteria:

• not mentally able to give written consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control group; No indication for stapedotomy
Distortion positive; Subjects after stapedotomy perceiving sound distortions
Distortion negative; Subjects after stapedotomy not perceiving sound distortions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of distorted sound perception after stapedotomy 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.	7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire on quality of hearing after Stapedotomy (APOSE)	Questionnaire	7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss National Science Foundation
• Investigators: Study Chair: Alexander Huber, Prof., USZ

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimated): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AH-RG_03_06_2014