Hearing Loss
Conditions
Keywords
Hearing changes, Non-surgical ear, Hearing loss, Vibration exposure, Skull-based surgery, Un-operated ear
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTDistortion product otoacoustic emissions (DPOAE)
Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Pittsburgh
Gateway Biotechnology, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency | pre-surgery, immediately after surgery, up to one month after surgery | DPOAE measurement using Interacoustics Titan DPOAE440 measurement tool is 5dB or greater from pre-surgery measurement to post-surgery measurement |
| Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements | pre-surgery, immediately after surgery | DPOAE measurement using interacoustics titan measurement tool has not changed or is less than 5dB from pre-surgery measurement to post-surgery measurement |
Countries
United States
Outcome results
None listed