NCT02856659

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

July 29, 2016

Last Update Submit

August 4, 2016

Conditions

Sensory Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults and children 12 years of age and older.

You may qualify if:

  • Subjects with sensorineural hearing loss
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lori O'Neil, Au.D

    Cochlear

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 5, 2016

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share