Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-03-24 @ 12:39 PM
Study NCT ID:
NCT03143257
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ambispective Clinical Evaluation of Sophono™
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006314', 'term': 'Hearing Loss, Conductive'}, {'id': 'D046089', 'term': 'Hearing Loss, Mixed Conductive-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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rs.entgm@medtronic.com', 'phone': '904-296-9600', 'title': 'Sr Manager, Clinical Affairs', 'organization': 'Medtronic Xomed'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from each subject at the single study visit which occurred at a range of 3 months to 5 years post-implantation. The collective Adverse Events in this study represent a range of time from implantation to the study visit (3 months to 5 years post implantation).', 'description': 'All adverse events present at the prospective visit were collected. Only treatment (surgical procedure or device) related events were collected retrospectively.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All Study Participants', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 9, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Implant Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incision Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Medical Device Site Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All Study Participants'}], 'classes': [{'categories': [{'measurements': [{'value': '0.038', 'groupId': 'OG000', 'lowerLimit': '0.018', 'upperLimit': '0.070'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Implantation to Study Visit, up to 6 years', 'description': 'The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam.', 'unitOfMeasure': 'Proportion of Adverse Events', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}, {'units': 'Ears', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'None AC', 'description': 'Unaided without the processor (Air Conduction)'}, {'id': 'OG001', 'title': 'None BC', 'description': 'Unaided without the processor (Bone Conduction)'}, {'id': 'OG002', 'title': 'Aided Alpha 2', 'description': 'Aided Alpha 2'}, {'id': 'OG003', 'title': 'Aided Alpha 2 MPO', 'description': 'Aided Alpha 2 MPO Processor'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '26.8', 'groupId': 'OG001'}, {'value': '39.4', 'spread': '11.2', 'groupId': 'OG002'}, {'value': '35.7', 'spread': '11.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '38.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '43.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '20.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry.', 'unitOfMeasure': 'decibles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Ears', 'denomUnitsSelected': 'Ears', 'populationDescription': '69 participants had prospective data (72 ears) and no data was obtained for 2 subjects (deviations noted) so the number of ears analyzed was 70 (67 subjects).'}, {'type': 'SECONDARY', 'title': 'Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}, {'units': 'ears', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Processor (Air Conduction)', 'description': 'The processors were tested in random order (e.g. subjects were tested with both the Alpha 2 processor and the Alpha 2 MPO processor separately but in random order). The participant was unaware which was being used for each test (the processors look the same, differences are internal and not visible). The tests were conducted four times, once for each processor and once with no processor (Air Conduction) and once with the lab standard vibration device (Bone Conduction).'}, {'id': 'OG001', 'title': 'Standard Vibration Device (Bone Conduction)', 'description': 'The processors were tested in random order (e.g. subjects were tested with both the Alpha 2 processor and the Alpha 2 MPO processor separately but in random order). The participant was unaware which was being used for each test (the processors look the same, differences are internal and not visible). The tests were conducted four times, once for each processor and once with no processor (Air Conduction) and once with the lab standard vibration device (Bone Conduction).'}, {'id': 'OG002', 'title': 'Alpha 2 Processor', 'description': 'The processors were tested in random order (e.g. subjects were tested with both the Alpha 2 processor and the Alpha 2 MPO processor separately but in random order). The participant was unaware which was being used for each test (the processors look the same, differences are internal and not visible). The tests were conducted four times, once for each processor and once with no processor (Air Conduction) and once with the lab standard vibration device (Bone Conduction).'}, {'id': 'OG003', 'title': 'Alpha 2 MPO Processor', 'description': 'The processors were tested in random order (e.g. subjects were tested with both the Alpha 2 processor and the Alpha 2 MPO processor separately but in random order). The participant was unaware which was being used for each test (the processors look the same, differences are internal and not visible). The tests were conducted four times, once for each processor and once with no processor (Air Conduction) and once with the lab standard vibration device (Bone Conduction).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '23.2', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '11.1', 'groupId': 'OG002'}, {'value': '36.0', 'spread': '11.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'All participants were tested with both the Alpha 2 and Alpha 2 MPO processor and also with no processor (Air Conduction) and a standard lab vibration device (Bone Conduction). The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor compared to the PTA aided by Alpha 2 MPO processor.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ears', 'denomUnitsSelected': 'ears', 'populationDescription': '69 subjects (N=72 implanted ears) were used to evaluate the primary effectiveness endpoint. 69 of 71 enrolled subjects were included in the effectiveness analysis. Two subjects did not have prospective data available: one did not have prospective audiologic exams completed and the other subject had audiologic data removed from analysis at the recommendation of the treating sub-investigator who felt the data collected to be inaccurate based on subject response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied After System Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All Study Participants'}], 'classes': [{'title': 'Satisfied with the processor', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied with appearance', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Would recommend device to another patient', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Subject satisfaction, via non-validated satisfaction questions', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess QOL After System Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'units': 'Subject Responses', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aided With Processor', 'description': 'In this arm all participants responded to the questions based on when they are wearing their own Sophono device (i.e. either the Sophono Alpha 2 or the Alpha 2 MPO).'}, {'id': 'OG001', 'title': 'Unaided Without Processor', 'description': 'In this arm all participants responded to the questions based on when they are not wearing their own hearing device.'}], 'classes': [{'title': 'Ease of Communication (%)', 'categories': [{'measurements': [{'value': '25.4', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '28.3', 'groupId': 'OG001'}]}]}, {'title': 'Reverberation (%)', 'categories': [{'measurements': [{'value': '32.4', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Background Noise (%)', 'categories': [{'measurements': [{'value': '33.0', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Aversiveness (%)', 'categories': [{'measurements': [{'value': '44.3', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Global Score (%)', 'categories': [{'measurements': [{'value': '30.3', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Overall Benefit Score', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-15', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.5', 'estimateComment': 'The overall benefit can be determined by subtracting the aided and unaided scores of Ease of Communication, Reverberation, Background Noise \\& Aversiveness. A negative score in overall benefit indicates a positive benefit to the subject.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment. The APHAB is a questionnaire with four subscales (Ease of Communication, Reverberation, Background Noise, and Aversiveness). Items are answered on a seven-point scale from "always" to "never". Scores for subscales can range from 0% (no difficulty) to 99% (maximum difficulty). Negative scores reflect a better benefit from aided hearing all subcategories are reported in percentiles. Abbreviated Profile of Hearing Aid Benefit was taken at 1 time point. Per request of site Institutional Review Board (IRB) pediatric patients were given a pediatric version. Calculation compared aided to unaided hearing.\n\nA global score is computed by averaging the East of Communication, Reverberation, and Background Noise scale scores. Questions are answered for unaided and aided listening. Aided scores are subtracted from unaided scores.', 'unitOfMeasure': 'Percentage of Score (hearing problem)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Responses', 'denomUnitsSelected': 'Subject Responses', 'populationDescription': 'In this study 63 of 71 subjects completed the APHAB.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sophono Implant', 'description': 'All Study Participants that have had a previous Sophono Bone Conduction Hearing System implant. No interventions were administered.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}]}, {'units': 'Ears', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All Study Participants'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}]}, {'units': 'Ears', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}]}, {'units': 'Ears', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'Ears', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}]}, {'units': 'Ears', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Ears', 'populationDescription': '71 participants were enrolled, 3 presented with bilateral device use which amounted to 74 enrolled ears.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-17', 'size': 508375, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-13T11:42', 'hasProtocol': True}, {'date': '2018-04-27', 'size': 325489, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-06T09:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2017-05-01', 'resultsFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-18', 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant', 'timeFrame': 'From Implantation to Study Visit, up to 6 years', 'description': 'The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam.'}, {'measure': 'Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor', 'timeFrame': '1 day', 'description': 'The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry.'}], 'secondaryOutcomes': [{'measure': 'Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor', 'timeFrame': '1 day', 'description': 'All participants were tested with both the Alpha 2 and Alpha 2 MPO processor and also with no processor (Air Conduction) and a standard lab vibration device (Bone Conduction). The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor compared to the PTA aided by Alpha 2 MPO processor.'}, {'measure': 'Percentage of Participants Satisfied After System Use', 'timeFrame': '1 day', 'description': 'Subject satisfaction, via non-validated satisfaction questions'}, {'measure': 'Assess QOL After System Use', 'timeFrame': '1 day', 'description': 'QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment. The APHAB is a questionnaire with four subscales (Ease of Communication, Reverberation, Background Noise, and Aversiveness). Items are answered on a seven-point scale from "always" to "never". Scores for subscales can range from 0% (no difficulty) to 99% (maximum difficulty). Negative scores reflect a better benefit from aided hearing all subcategories are reported in percentiles. Abbreviated Profile of Hearing Aid Benefit was taken at 1 time point. Per request of site Institutional Review Board (IRB) pediatric patients were given a pediatric version. Calculation compared aided to unaided hearing.\n\nA global score is computed by averaging the East of Communication, Reverberation, and Background Noise scale scores. Questions are answered for unaided and aided listening. Aided scores are subtracted from unaided scores.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Conductive Hearing Loss', 'Single-Sided Deafness', 'Mixed Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subject population for this study includes male and female patients 5 years of age and older who have received the Sophono implant. Subjects will be recruited from Investigators who have implanted Sophono systems or from other non-investigator physician referrals. Subjects are expected to represent a population diagnosed with conductive hearing loss (CHL), single-sided deafness (SSD), and mixed hearing loss (HL).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any subject who currently has or who has had the Sophono implant (including those who have been explanted)\n* Has or has had Sophono implant for 3 months or longer\n\nExclusion Criteria:\n\n* Subject has implant but is unable or unwilling to perform audiologic testing\n* Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor'}, 'identificationModule': {'nctId': 'NCT03143257', 'acronym': 'ACES', 'briefTitle': 'Ambispective Clinical Evaluation of Sophono™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Surgical Technologies'}, 'officialTitle': 'Ambispective Clinical Evaluation of Sophono™', 'orgStudyIdInfo': {'id': 'MDT16043ENT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects', 'description': 'Diagnosed with Conductive Hearing Loss (CHL), Single-Sided Deafness (SSD)and mixed Hearing Loss (HL) who currently have or have had the Sophono implant', 'interventionNames': ['Device: Sophono Bone Conduction Hearing Systems']}], 'interventions': [{'name': 'Sophono Bone Conduction Hearing Systems', 'type': 'DEVICE', 'description': 'The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of Bone Conduction (BC) of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea.\n\nThe Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear.', 'armGroupLabels': ['Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Macias Otology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health ENT and Allergy', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Specialty Care", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Park Avenue Otology/Neurotology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Ear & Hearing Clinic', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pittsburgh Ear Associates', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Surgical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}