Clinical trial NCT05250414: Single-Sided Deafness in the Medicare Population
Official title: Cochlear Implantation in the Single-Sided Deafness in the Medicare Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Unilateral
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

Detailed description: The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older at the time of implantation
* 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:

* Duration of profound hearing loss of 10 years or more
* 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

Primary outcomes:
measure: Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.
timeFrame: One year (12 months) post implantation
Secondary outcomes:
measure: Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation.
timeFrame: One year (12 months) post implantation
measure: Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation.
timeFrame: One year (12 months) post implantation
measure: Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation.
timeFrame: One year (12 months) post implantation
measure: Safety will be evaluated for all study subjects through one year (12 months) post implantation.
timeFrame: One year (12 months) post implantation
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.