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Evaluation of N6 Sound Processor in Group of Freedom Users

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ClinicalTrials.gov Identifier: NCT02856659
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.

Condition or disease
Sensory Hearing Loss

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of N6 Sound Processor in Group of Freedom Users
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Evaluation of N6 Sound Processor in Group of Freedom Users [ Time Frame: 3 months of use ]
    Speech recognition measures in quiet & noise via word and sentence rest and SSiQ questionnaire to compare freedom to upgrade with N6 relative to speech, spatial and quality dimensions and N6 questionnaire.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults and children 12 years of age and older.
Criteria

Inclusion Criteria:

  • Subjects with sensorineural hearing loss
  • 12 years of age and older
  • Currently using Freedom Sound Processor
  • Recipient of a Ci22M or CI24 series implant
  • Minimum of 3 months experience with Freedom Sound Processor
  • Prior documentation of sentence recognition in noise at a +10 SNR or better
  • Native English speaker
  • Willingness to participate and comply with requirements of protocol

Exclusion Criteria:

  • Unable to complete test metrics
  • Unrealistic expectations regarding possible benefits
  • Additional handicaps that would prevent or restrict participation in audiological evaluations
  • ABI cochlear implant recipient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856659


Sponsors and Collaborators
Cochlear
Investigators
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Study Director: Lori O'Neil, Au.D Cochlear

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02856659     History of Changes
Other Study ID Numbers: CAM5623-FRN6
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms