Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-06 @ 6:07 AM
Study NCT ID:
NCT02042404
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
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': 'slevy@earlenscorp.com', 'phone': '650 366 9000', 'title': 'Dr. Suzanne Levy, Director of Clinical Research', 'organization': 'EarLens Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mild to Severe Hearing Impairment', 'description': 'Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.', 'otherNumAtRisk': 48, 'otherNumAffected': 25, 'seriousNumAtRisk': 48, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abrasion/Blood blister in the ear canal', 'notes': 'Device related, anticipated, mild, all resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Abrasion/Blood/Blister on tympanic membrane', 'notes': 'Device related, anticipated, mild, all resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Ear discomfort/pain', 'notes': 'Device related, anticipated, mild/moderate, all resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Ear tip, other: swelling, itching', 'notes': 'Device related, anticipated, mild/moderate, all resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Inflammation/Granulation tissue on tympanic membrane', 'notes': 'Device related, anticipated, mild, all resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Pain upon eructation/ valsalva', 'notes': 'Device related, anticipated, mild, all resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Pressure sensation of device on tympanic membrane', 'notes': 'Device related, anticipated, mild, ongoing as subject continues to wear the device..', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}], 'seriousEvents': [{'term': 'Altered mental status', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hospitalized for bike accident', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Drug overdose leading to death', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Bacterial pneumonia', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hospitalized for heart issues', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Cohort: Mild to Severe Hearing Impairment', 'description': 'Sound amplification provided via the EarLens System assistive hearing device.\n\nSound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.'}, {'id': 'OG001', 'title': 'Roll-in Cohort: Mild to Severe Hearing Impairment', 'description': 'Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '24.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'repeated measures ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 days', 'description': 'Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.', 'unitOfMeasure': 'percentage of words correctly identified', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '39 subjects available for analysis between enrollment/treatment and 30 day measurement.'}, {'type': 'PRIMARY', 'title': 'Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild to Severe Hearing Impairment', 'description': 'Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3983', 'spread': '2.9822', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'repeated measures ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 120 days', 'description': 'The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of "No Hearing Change" for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less.', 'unitOfMeasure': 'dB difference in Unaided Hearing', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '43 subjects available for analysis between enrollment/treatment and 120 day measurement.'}, {'type': 'SECONDARY', 'title': 'Functional Gain Over the Frequency Range From 2000 to 10,000 Hz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Cohort: Mild to Severe Hearing Impairment', 'description': 'Sound amplification provided via the EarLens System assistive hearing device.\n\nSound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.'}, {'id': 'OG001', 'title': 'Roll-in Cohort: Mild to Severe Hearing Impairment', 'description': 'Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4819', 'spread': '10.2504', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'repeated measures ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 days', 'description': '10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.', 'unitOfMeasure': 'dB difference in Soundfield Hearing', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '39 subjects available for analysis between enrollment/treatment and 30 day measurement.'}, {'type': 'SECONDARY', 'title': 'Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Cohort: Mild to Severe Hearing Impairment', 'description': 'Sound amplification provided via the EarLens System assistive hearing device.\n\nSound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.'}, {'id': 'OG001', 'title': 'Roll-in Cohort: Mild to Severe Hearing Impairment', 'description': 'Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7542', 'spread': '4.2207', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0281', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'repeated measures ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 days', 'description': 'Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.', 'unitOfMeasure': 'dB difference in HINT scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '39 subjects available for analysis between enrollment/treatment and 30 day measurement.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Determine the Incidence of Serious Device- and Procedure-related Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild to Severe Hearing Impairment', 'description': 'Sound amplification provided via the EarLens System assistive hearing device.\n\nSound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '120 days', 'description': 'The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.', 'unitOfMeasure': 'serious device- or procedure-related AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Both Primary Cohort and Roll-in Cohort were included in all safety analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Cohort: Mild to Severe Hearing Impairment', 'description': 'Sound amplification provided via the EarLens System assistive hearing device.\n\nSound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.'}, {'id': 'FG001', 'title': 'Roll-in Cohort: Mild to Severe Hearing Impairment', 'description': 'Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrollment was stopped after 43 were enrolled, had approval to enroll 45 primary cohort subjects', 'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '39 subjects completed 30 days evaluation. 38 subjects completed 120 days evaluation.', 'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unrelated Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Inability to meet time requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Flyers approved by WIRB for subject recruitment. Also referrals from local audiology clinics and otologists.', 'preAssignmentDetails': 'The first five (5) enrolled will be part of a pilot phase of the study to work out the process flow and training of the centers and participants, called "Roll-in Cohort."'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mild to Severe Hearing Impairment', 'description': 'Subjects wearing the Earlens System in their daily lives.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Both Primary Cohort and Roll-in Cohorts combined in Demographic Report'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2014-01-20', 'resultsFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine the Incidence of Serious Device- and Procedure-related Adverse Events.', 'timeFrame': '120 days', 'description': 'The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.'}], 'primaryOutcomes': [{'measure': 'Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.', 'timeFrame': 'Baseline and 30 days', 'description': 'Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.'}, {'measure': 'Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment', 'timeFrame': 'Baseline and 120 days', 'description': 'The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of "No Hearing Change" for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less.'}], 'secondaryOutcomes': [{'measure': 'Functional Gain Over the Frequency Range From 2000 to 10,000 Hz', 'timeFrame': 'Baseline and 30 days', 'description': '10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.'}, {'measure': 'Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.', 'timeFrame': 'Baseline and 30 days', 'description': 'Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hearing impairment', 'Hearing loss'], 'conditions': ['Hearing Impairment']}, 'referencesModule': {'references': [{'pmid': '23524632', 'type': 'BACKGROUND', 'citation': 'Fay JP, Perkins R, Levy SC, Nilsson M, Puria S. Preliminary evaluation of a light-based contact hearing device for the hearing impaired. Otol Neurotol. 2013 Jul;34(5):912-21. doi: 10.1097/MAO.0b013e31827de4b1.'}, {'pmid': '30300158', 'type': 'DERIVED', 'citation': 'Arbogast TL, Moore BCJ, Puria S, Dundas D, Brimacombe J, Edwards B, Carr Levy S. Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2. Ear Hear. 2019 May/Jun;40(3):741-756. doi: 10.1097/AUD.0000000000000661.'}], 'seeAlsoLinks': [{'url': 'http://www.earlenscorp.com', 'label': 'EarLens Corporation website'}]}, 'descriptionModule': {'briefSummary': 'The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of this multi-center definitive study is to assess the safety and efficacy of the EarLens System for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. This study is designed to support US and International marketing applications to commercialize the EarLens System. The main efficacy hypothesis is that the EarLens System will be shown to improve speech understanding in quiet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 85 years\n* Mild to severe hearing impairment between 125 to 4000 Hz\n* No significant conductive hearing impairment\n* Able and willing to commit to travel and time demands of the study\n\nExclusion Criteria:\n\n* Must not have known or active medical issues that would preclude having a device including:\n\n 1. an abnormal tympanic membrane\n 2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes\n 3. an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane\n* Must not have other known or active medical issues including:\n\n 1. history of chronic and recurrent ear infections in the past 24 mouths\n 2. history of dizziness and/or vertigo in the past 24 months\n 3. taking medications/treatments with known ototoxic effects\n 4. a rapidly progressive or fluctuating hearing impairment\n 5. having been diagnosed with having a compromised immune system\n* Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56\n* Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel'}, 'identificationModule': {'nctId': 'NCT02042404', 'briefTitle': 'The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'EarLens Corporation'}, 'officialTitle': 'The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study', 'orgStudyIdInfo': {'id': 'EarLens CRP00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild to severe hearing impairment', 'description': 'Sound amplification provided via the EarLens System assistive hearing device.', 'interventionNames': ['Device: Sound amplification provided via EarLens System.']}], 'interventions': [{'name': 'Sound amplification provided via EarLens System.', 'type': 'DEVICE', 'description': 'The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.', 'armGroupLabels': ['Mild to severe hearing impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': 'EarLens Corporation', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '95138', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Camino Ear Nose and Throat Clinic', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Bruce Gantz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics'}, {'name': 'Sunil Puria, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'EarLens Corp.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EarLens Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}