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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06189274
Other study ID # NSHSCMEDEL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date December 2025

Study information

Verified date December 2023
Source Nova Scotia Health Authority
Contact David P Morris, MD
Phone 902-473-1986
Email dp.morris@dal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.


Description:

To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging. Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants. All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date December 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older at the time of implantation - Unilateral severe to profound sensorineural hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 70 dB HL or greater - Normal hearing mild hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 40 dB or less - Deemed an appropriate candidate by the 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 using appropriate imaging modality to be determined by the investigator - 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


Related Conditions & MeSH terms


Intervention

Other:
Anatomy-Based Electrode Array Selection
Use of pre-operative imaging to select the appropriate length electrode vs standard of care
Standard of Care Electrode Array Selection
Use of standard of care electrode which is the FLEX 28 electrode

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Nova Scotia Health Authority Med-El Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary Speech perception in spatially separated noise Change in percent correct on the AzBio sentences in noise, with speech presented to the front and noise to the better hearing ear 6 months post activation
Secondary Speech perception in noise Change in percent correct on the AzBio sentences in noise, in two conditions. Condition 1 is with speech and noise both presented to the front. Condition 2 is with speech presented from the front and noise presented to the CI ear 6 months post activation
Secondary Speech perception in quiet Change in percent correct on the CNC words in quiet in implanted ear. 6 months post activation
Secondary Speech Spatial and Qualities of Hearing Scale (SSQ) Subjective questionnaire on speech perception and sound quality 6 months post activation
Secondary Datalogging Evaluate average daily device use 6 months post activation
See also
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