Anatomy Based Selection of CI Array for SSD Patients

NCT06189274 | Unknown FDA Device

• 1 other identifier: NSHSCMEDEL
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Single-Sided Deafness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Speech perception in noise

  6 months post activation

• Speech perception in quiet

  6 months post activation

• Speech Spatial and Qualities of Hearing Scale (SSQ)

  6 months post activation

• Datalogging

  6 months post activation

Study Arms (2)

Anatomy-Based Electrode Selection

EXPERIMENTAL

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.

Other: Anatomy-Based Electrode Array Selection

Standard of Care Electrode Selection

ACTIVE COMPARATOR

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.

Other: Standard of Care Electrode Array Selection

Interventions

Anatomy-Based Electrode Array Selection OTHER

Use of pre-operative imaging to select the appropriate length electrode vs standard of care

Also known as: OTOPLAN

Anatomy-Based Electrode Selection

Standard of Care Electrode Array Selection OTHER

Use of standard of care electrode which is the FLEX 28 electrode

Standard of Care Electrode Selection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Med-El Corporation: collaborator

Central Study Contacts

David P Morris, MD

CONTACT

902-473-1986; dp.morris@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share