Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-01-22 @ 2:17 AM
Study NCT ID:
NCT02856659
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2016-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of N6 Sound Processor in Group of Freedom Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-04', 'studyFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of N6 Sound Processor in Group of Freedom Users', 'timeFrame': '3 months of use', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sensory Hearing Loss']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and children 12 years of age and older.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with sensorineural hearing loss\n* 12 years of age and older\n* Currently using Freedom Sound Processor\n* Recipient of a Ci22M or CI24 series implant\n* Minimum of 3 months experience with Freedom Sound Processor\n* Prior documentation of sentence recognition in noise at a +10 SNR or better\n* Native English speaker\n* Willingness to participate and comply with requirements of protocol\n\nExclusion Criteria:\n\n* Unable to complete test metrics\n* Unrealistic expectations regarding possible benefits\n* Additional handicaps that would prevent or restrict participation in audiological evaluations\n* ABI cochlear implant recipient'}, 'identificationModule': {'nctId': 'NCT02856659', 'briefTitle': 'Evaluation of N6 Sound Processor in Group of Freedom Users', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Evaluation of N6 Sound Processor in Group of Freedom Users', 'orgStudyIdInfo': {'id': 'CAM5623-FRN6'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': "Lori O'Neil, Au.D", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cochlear'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}