Single-Sided Deafness in the Medicare Population

Hearing Loss, Unilateral Clinical Trial

Official title:

Cochlear Implantation in the Single-Sided Deafness in the Medicare Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250414
• Other study ID #: MED-EL SSD CMS
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Unilateral

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

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

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

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. — 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	Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 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 6-month and 12-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.	One year (12 months) post implantation
Secondary	Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 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 6- and 12-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)	One year (12 months) post implantation
Secondary	Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation.	Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 6-month, and 12-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)	One year (12 months) post implantation
Secondary	Subjective benefit of the Cochlear Implant System will be assessed through one year (12 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, 6-month, and 12-month intervals. (Range of score 0-10, lower score is better)	One year (12 months) post implantation
Secondary	Safety will be evaluated for all study subjects through one year (12 months) 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.	One year (12 months) post implantation