Anatomy Based Selection of CI Array for SSD Patients

Not Applicable

Not yet recruiting

• Conditions: Single-Sided Deafness
• Interventions: Other: Anatomy-Based Electrode Array Selection; Other: Standard of Care Electrode Array Selection

• Registration Number: NCT06189274
• Lead Sponsor: Nova Scotia Health Authority

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Study Start: 2024-04
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anatomy-Based Electrode Selection	Anatomy-Based Electrode Array Selection	For individuals in the anatomy-based electrode (ABE) group, magnetic resolution imaging (MRI) or computed tomography (CT) scans will be evaluated by MED-EL Canada employees. Based on these results, an appropriate electrode array will be selected.
Standard of Care Electrode Selection	Standard of Care Electrode Array Selection	The comparison in this study will be to current standard of care, which is to select a single electrode length for most patients, in this case the FLEX28 electrode, which is 28 mm long.

Primary Outcome Measures

Name	Time	Method
Speech perception in spatially separated noise	6 months post activation	Change in percent correct on the AzBio sentences in noise, with speech presented to the front and noise to the better hearing ear

Secondary Outcome Measures

Name	Time	Method
Speech perception in noise	6 months post activation	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
Datalogging	6 months post activation	Evaluate average daily device use
Speech perception in quiet	6 months post activation	Change in percent correct on the CNC words in quiet in implanted ear.
Speech Spatial and Qualities of Hearing Scale (SSQ)	6 months post activation	Subjective questionnaire on speech perception and sound quality