Hearing Changes After Surgery

Gateway Biotechnology

Status: Withdrawn

Conditions: Hearing Loss

Treatments: Diagnostic Test: Distortion product otoacoustic emissions (DPOAE)

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT04322747

3R41DC017406-01S1 (U.S. NIH Grant/Contract)

19090236

Details and patient eligibility

About

The purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surgeries

Full description

High-speed drills that are capable of producing elevated levels are used during skull based surgeries (Hilmi et al., 2011; Yu et al., 2014). Recently, it has been shown that surgical drilling may have a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (Baradaranfar et al., 2015; Shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. This study aims to to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the non operative ear, during surgical site during skull-based or mastoid surgeries. As part of the study patient will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear
• participants have normal or near-normal hearing thresholds in the un-operated ear

Exclusion criteria

• participants have hearing loss (PTA > 40 dB HL) in pure tone audiometry testing before surgery in the un-operated ear
• participants have medical conditions after the surgery which prevents having hearing tests
• participants have abnormal tympanometric results

Trial design

0 participants in 1 patient group

Participants scheduled to undergo skull-based surgery

Description:

Participants scheduled to undergo skull-based or mastoid surgery as part of their standard care will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure in the non operated ear.

Treatment:

Diagnostic Test: Distortion product otoacoustic emissions (DPOAE)