Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-11 @ 4:23 AM
Study NCT ID:
NCT01861704
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-market Study to Capture Information Regarding Performance of Lyric2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Srikant.Mantha@phonak.com', 'phone': '510-792-4000', 'title': 'Tanya Arbogast, Study Principal Investigator', 'organization': 'InSound Medical, Newark, California'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lyric', 'description': 'Silver Lyric device\n\nLyric: Extended wear hearing instrument', 'otherNumAtRisk': 70, 'otherNumAffected': 4, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lyric2', 'description': 'Lyric2 (Barracuda) device\n\nLyric: Extended wear hearing instrument', 'otherNumAtRisk': 107, 'otherNumAffected': 6, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sound Quality -> Fine tuning', 'notes': 'Complaint in follow up or on the phone No removal, only fine tuning the settings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acoustic Feedback -> Removal', 'notes': 'Complaint in follow up or on the phone, device got removed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort / Pain -> Removal', 'notes': 'Complaint in follow up or on the phone, device got removed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Handling -> Removal', 'notes': 'Handling issues, patient removed the device himself not knowing that it cannot be reinserted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sound Quality -> Removal', 'notes': 'Sound quality issues with the device leading to a removal and exchange of the hearing aid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Handling -> Fine tuning', 'notes': 'Issue with handling of the device that could be resolved by retraining the patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immediate Refit Upon Device Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Experienced ears', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lyric', 'description': 'Silver Lyric device\n\nLyric: Extended wear hearing instrument\n\nOnly experienced ears counted'}, {'id': 'OG001', 'title': 'Lyric2', 'description': 'Lyric2 (Barracuda) device\n\nLyric: Extended wear hearing instrument\n\nOnly experienced ears counted'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '86'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Following device removal at the same appointment (Up to 24 hours after removal)', 'description': "Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.", 'unitOfMeasure': 'percentage of ears', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Experienced ears', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument'}, {'type': 'SECONDARY', 'title': 'Device Comfort', 'timeFrame': 'During useful lifespan of device', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Gain, Speech Understanding and Sound Quality', 'timeFrame': 'During useful lifespan of device', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lyric', 'description': 'Silver Lyric device\n\nLyric: Extended wear hearing instrument'}, {'id': 'FG001', 'title': 'Lyric2', 'description': 'Lyric2 (Barracuda) device\n\nLyric: Extended wear hearing instrument'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients are fitted according to their ear size and experience level. Patients with a different experience level for each ear are only counted once.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lyric', 'description': 'Silver Lyric device\n\nLyric: Extended wear hearing instrument'}, {'id': 'BG001', 'title': 'Lyric2', 'description': 'Lyric2 (Barracuda) device\n\nLyric: Extended wear hearing instrument'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years of age', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '>18 years of age', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2013-03-21', 'resultsFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-16', 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate Refit Upon Device Removal', 'timeFrame': 'Following device removal at the same appointment (Up to 24 hours after removal)', 'description': "Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear."}], 'secondaryOutcomes': [{'measure': 'Device Comfort', 'timeFrame': 'During useful lifespan of device'}, {'measure': 'Gain, Speech Understanding and Sound Quality', 'timeFrame': 'During useful lifespan of device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mild to moderate hearing loss'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.', 'detailedDescription': 'Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-90 years at the time of enrollment in the study\n* Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear\n* Fluent in English\n* Willingness to comply with all study requirements\n\nExclusion Criteria:\n\n* Scuba dives or sky dives\n* Underwater swimming or dives into the water\n* Handicaps that would restrict participation in all the evaluations\n* Hearing loss of neural or central origin\n* Unrealistic expectations regarding benefits and limitations inherent in the devices\n* Chemotherapy within the last six months\n* Compromised immune system\n* Radiation to head or neck\n* Perforated tympanic membrane\n* History of cholesteatoma\n* Active outer or middle ear pathology\n* High levels of anticoagulant therapy\n* Insulin-dependent and/or uncontrolled diabetes\n* Contact dermatitis\n* Bleeding disorder\n* Unwillingness or inability to comply with all study requirements'}, 'identificationModule': {'nctId': 'NCT01861704', 'briefTitle': 'Post-market Study to Capture Information Regarding Performance of Lyric2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phonak AG, Switzerland'}, 'officialTitle': 'Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric', 'orgStudyIdInfo': {'id': '000.000.004.858'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lyric', 'description': 'Silver Lyric device', 'interventionNames': ['Device: Lyric']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lyric2', 'description': 'Lyric2 (Barracuda) device', 'interventionNames': ['Device: Lyric2']}], 'interventions': [{'name': 'Lyric', 'type': 'DEVICE', 'description': 'Extended wear hearing instrument', 'armGroupLabels': ['Lyric']}, {'name': 'Lyric2', 'type': 'DEVICE', 'description': 'Extended wear hearing instrument', 'armGroupLabels': ['Lyric2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94560', 'city': 'Newark', 'state': 'California', 'country': 'United States', 'facility': 'InSound Medical', 'geoPoint': {'lat': 37.52966, 'lon': -122.04024}}], 'overallOfficials': [{'name': 'Tanya Arbogast', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phonak AG, Switzerland', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}