Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oticon Medical
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- speech recognition in quiet
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
speech recognition in quiet
Time Frame: Day 1
Hearing In Noise Test
Secondary Outcomes
- speech recognition in noise(Day 1)
- pure tone threshold(Day 1)