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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04506853
Other study ID # P000025/S113
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date September 2026

Study information

Verified date March 2024
Source Med-El Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date September 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility 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

Study Design


Intervention

Device:
MED-EL Cochlear Implant System
Cochlear implant and audio processor

Locations

Country Name City State
Canada Sunnybrook Health Sciences Center Toronto Ontario
United States University of North Carolina Chapel Hill North Carolina
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States University of Iowa Iowa City Iowa
United States New York Eye and Ear Infirmary New York New York
United States Virginia Mason Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Med-El Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points. Three years (36 months) post implantation
Secondary 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 Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better) Three years (36 months) post implantation
Secondary Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better) Three years (36 months) post implantation
Secondary Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better) Three years (36 months) post implantation
Secondary Long term safety will be evaluated for all study subjects through three (36 months) years post implantation Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event. Three years (36 months) post implantation
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