Anatomy Based Selection of CI Array for SSD Patients

NCT ID: NCT06189274

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-12-31

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.

Conditions

Single-Sided Deafness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anatomy-Based Electrode 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.

Group Type: EXPERIMENTAL

Anatomy-Based Electrode Array Selection

Intervention Type: OTHER

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

Standard of Care Electrode 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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Electrode Array Selection

Intervention Type: OTHER

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

Interventions

Anatomy-Based Electrode Array Selection

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

Intervention Type: OTHER

Standard of Care Electrode Array Selection

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

Intervention Type: OTHER

Other Intervention Names

OTOPLAN

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Med-El Corporation

INDUSTRY

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

David P Morris, MD

Role: CONTACT

dp.morris@dal.ca

902-473-1986

Other Identifiers

NSHSCMEDEL

Identifier Type: -

Identifier Source: org_study_id