Single-Sided Deafness
Conditions
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.
Interventions
OTHERAnatomy-Based Electrode Array Selection
Use of pre-operative imaging to select the appropriate length electrode vs standard of care
OTHERStandard of Care Electrode Array Selection
Use of standard of care electrode which is the FLEX 28 electrode
Sponsors
Med-El Corporation
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Datalogging | 6 months post activation | Evaluate average daily device use |
| Speech Spatial and Qualities of Hearing Scale (SSQ) | 6 months post activation | Subjective questionnaire on speech perception and sound quality |
| 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 |
| Speech perception in quiet | 6 months post activation | Change in percent correct on the CNC words in quiet in implanted ear. |
Contacts
Primary ContactDavid P Morris, MD
Outcome results
None listed