Back to resultsNeuro 1 vs. Neuro 2 Sound Processors
Primary Purpose
Hearing Loss, Sensorineural, Cochlear Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neuro 1 & Neuro 2
Neuro 2 & Neuro 1
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Sensorineural focused on measuring cochlear implant, sound processor, upgrade
Eligibility Criteria
Inclusion Criteria:
- written informed consent
- primary implantation
- subject having participated to previous Neuro 1 sound processor study in Canada
- fluent in English, including reading and writing.
Exclusion Criteria:
- psychologically unsuitable
- unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
- non compliant with all investigational requirements.
Sites / Locations
- Nova Scotia Hearing and Speech centres
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Neuro 2 Upgrade
Neuro 1 Downgrade
Arm Description
Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.
Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.
Outcomes
Primary Outcome Measures
speech recognition in quiet
Hearing In Noise Test
Secondary Outcome Measures
speech recognition in noise
Hearing In Noise Test
pure tone threshold
from 250Hz to 8kHz
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03756337
Brief Title
Neuro 1 vs. Neuro 2 Sound Processors
Official Title
Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.
Detailed Description
The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Cochlear Hearing Loss
Keywords
cochlear implant, sound processor, upgrade
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuro 2 Upgrade
Arm Type
Experimental
Arm Description
Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.
Arm Title
Neuro 1 Downgrade
Arm Type
Experimental
Arm Description
Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.
Intervention Type
Device
Intervention Name(s)
Neuro 1 & Neuro 2
Intervention Description
participant common fitting map used for tests
Intervention Type
Device
Intervention Name(s)
Neuro 2 & Neuro 1
Intervention Description
participant common fitting map used for tests
Primary Outcome Measure Information:
Title
speech recognition in quiet
Description
Hearing In Noise Test
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
speech recognition in noise
Description
Hearing In Noise Test
Time Frame
Day 1
Title
pure tone threshold
Description
from 250Hz to 8kHz
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
written informed consent
primary implantation
subject having participated to previous Neuro 1 sound processor study in Canada
fluent in English, including reading and writing.
Exclusion Criteria:
psychologically unsuitable
unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
non compliant with all investigational requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Peter Morris, MD
Organizational Affiliation
Dalhousie University, Halifax,NS, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Hearing and Speech centres
City
Halifax
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Neuro 1 vs. Neuro 2 Sound Processors
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