Anatomy Based Selection of CI Array for SSD Patients

Nova Scotia Health Authority10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Single-Sided Deafness

Interventions

Anatomy-Based Electrode Array SelectionOTHER

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

Standard of Care Electrode Array SelectionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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