Hearing Loss, UnilateralNCT04506853
Single-Sided Deafness and Asymmetric Hearing Loss
A study testing MED-EL Cochlear Implant System in people with Hearing Loss, Unilateral and Hearing Loss, Sensorineural, run by Med-El Corporation at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hearing Loss, Unilateral, Hearing Loss, Sensorineural
- What is being tested?
- MED-EL Cochlear Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Feb 2021to 21 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of North Carolina
Chapel Hill, North Carolina, 27517
University of Iowa
Iowa City, Iowa, 52242-1078
New York Eye and Ear Infirmary
New York, New York, 10003
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
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.
Read the 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.
- Being tested
- MED-EL Cochlear Implant System
- Medical subject headings
- Hearing Loss, Unilateral, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-EL Cochlear Implant SystemDevice
Cochlear implant and audio processor
| Study group | Role | What they receive |
|---|---|---|
| Study Procedure | Other | Not described Receives: Device: MED-EL Cochlear Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years (36 months) post implantation
Secondary outcomes (4)
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)
Measured: Three years (36 months) post implantation
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)
Measured: Three years (36 months) post implantation
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)
Measured: Three years (36 months) post implantation
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.
Measured: Three years (36 months) post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start22 Feb 2021
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506853
- Sponsor's protocol ID
- P000025/S113
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 28188428Arndt 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.
PubMed 25999052Buss 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.
PubMed 29732951Dillon 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.
PubMed 29298446Niparko 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.
PubMed 12544032Van 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.
PubMed 18834065Vermeire 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.
PubMed 19005250