Hearing Changes After Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Hearing Changes After Skull Base and Mastoid Surgery

Conditions
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Hearing Loss

Intervention / Treatment
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* Diagnostic Test: Distortion product otoacoustic emissions (DPOAE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants scheduled to undergo skull-based surgery<br>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. | Diagnostic Test: Distortion product otoacoustic emissions (DPOAE)<br>* Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.<br>* Other names: Audiometry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | pre-surgery, immediately after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing changes, Non-surgical ear, Hearing loss, Vibration exposure, Skull-based surgery, Un-operated ear