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Distortion Product After Stapedotomy Surgery

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Distorted Sound Perception

Study type

Observational

Funder types

Other

Identifiers

NCT02245646
AH-RG_03_06_2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • indication for stapedotomy
  • written consent given

Exclusion criteria

  • not mentally able to give written consent

Trial design

60 participants in 3 patient groups

Control group
Description:
No indication for stapedotomy
Distortion positive
Description:
Subjects after stapedotomy perceiving sound distortions
Distortion negative
Description:
Subjects after stapedotomy not perceiving sound distortions.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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