Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2022-06-27
2025-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Procedure
MED-EL Cochlear Implant System
Cochlear implant and audio processor
Interventions
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MED-EL Cochlear Implant System
Cochlear implant and audio processor
Eligibility Criteria
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Inclusion Criteria
* Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
* Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz
* Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less
* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
* Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
* Fluent in English
Exclusion Criteria
* Sudden onset of hearing loss within six months of implantation
* Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
* Evidence of severe cochlear malformation (i.e., common cavity or ossification)
* External or middle ear infection
* Suspected cognitive concern
* Other medical contraindication for surgery or anesthesia
65 Years
ALL
Yes
Sponsors
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Med-El Corporation
INDUSTRY
Responsible Party
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Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. HNO. 2017 Aug;65(Suppl 2):98-108. doi: 10.1007/s00106-016-0297-5.
Buss E, Dillon MT, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173.
Mertens G, De Bodt M, Van de Heyning P. Evaluation of Long-Term Cochlear Implant Use in Subjects With Acquired Unilateral Profound Hearing Loss: Focus on Binaural Auditory Outcomes. Ear Hear. 2017 Jan/Feb;38(1):117-125. doi: 10.1097/AUD.0000000000000359.
Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8. doi: 10.1097/00129492-200301000-00015.
Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903.
Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.
Other Identifiers
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MED-EL SSD CMS
Identifier Type: -
Identifier Source: org_study_id
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