Anatomy Based Selection of CI Array for SSD Patients

Single-Sided Deafness Clinical Trial

Official title:

Anatomy-Based Cochlear Implant Array Selection for Patients With Single-Sided Deafness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189274
• Other study ID #: NSHSCMEDEL
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Nova Scotia Health Authority
• Contact: David P Morris, MD
• Phone: 902-473-1986
• Email: dp.morris[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Single-Sided Deafness

Intervention

Other:
• Anatomy-Based Electrode Array Selection
Use of pre-operative imaging to select the appropriate length electrode vs standard of care
• Standard of Care Electrode Array Selection
Use of standard of care electrode which is the FLEX 28 electrode

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Med-El Corporation

Outcome

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