Hearing Changes After Surgery

Gateway Biotechnology, Inc.

Overview

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

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.

Study Type

OBSERVATIONAL

Conditions

Hearing Loss

Interventions

Distortion product otoacoustic emissions (DPOAE)DIAGNOSTIC_TEST

Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency

DPOAE measurement using Interacoustics Titan DPOAE440 measurement tool is 5dB or greater from pre-surgery measurement to post-surgery measurement

Time frame: pre-surgery, immediately after surgery, up to one month after surgery

Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements

DPOAE measurement using interacoustics titan measurement tool has not changed or is less than 5dB from pre-surgery measurement to post-surgery measurement

Time frame: pre-surgery, immediately after surgery

Data from ClinicalTrials.gov

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