NCT02934373WithdrawnNot Applicable
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Cochlear
- Locations
- 6
- Primary Endpoint
- Subjective rating with a new sound processor compared to ratings with each subjects own processor
Study Overview
Brief Summary
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •12 months old or older
- •Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
- •Use of the CP810, CP920 or CP910 sound processor
- •Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
- •Additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
- •Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device
Outcomes
Primary Outcomes
Subjective rating with a new sound processor compared to ratings with each subjects own processor
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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