Clinical trial NCT04506853: Single-Sided Deafness and Asymmetric Hearing Loss
Official title: Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Unilateral
Hearing Loss, Sensorineural
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-10
Enrollment: 65
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Detailed description: The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.

Eligibility criteria: Inclusion Criteria:

* Five 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 and a diagnosed pathology of the outer or middle ear
* Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 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 Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, 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
* Absence of cochlear development or non-functionality of cochlear nerve
* Other retrocochlear hearing loss
* Evidence of severe cochlear malformation (i.e., common cavity or ossification)
* External or middle ear infection
* Suspected developmental or cognitive concern
* Other medical contraindication for surgery or anesthesia

Primary outcomes:
measure: Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation
timeFrame: Three years (36 months) post implantation
Secondary outcomes:
measure: Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation
timeFrame: Three years (36 months) post implantation
measure: Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation
timeFrame: Three years (36 months) post implantation
measure: Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation
timeFrame: Three years (36 months) post implantation
measure: Long term safety will be evaluated for all study subjects through three (36 months) years post implantation
timeFrame: Three years (36 months) post implantation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
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: Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19.
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: Dillon MT, Buss E, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Audiol Neurootol. 2017;22(4-5):259-271. doi: 10.1159/000484079. Epub 2018 Jan 4.
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.