Evaluation of N6 Sound Processor in Group of Freedom Users

Sensory Hearing Loss Clinical Trial

Official title:

Evaluation of N6 Sound Processor in Group of Freedom Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856659
• Other study ID #: CAM5623-FRN6
• Status: Completed
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 4, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensory Hearing Loss

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of N6 Sound Processor in Group of Freedom Users	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.	3 months of use	No