Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT00747435
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2008-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of the MED-EL Electric-Acoustic System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], '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': 'clinicaltrials@medelus.com', 'title': 'Sr. Clinical Research Associate', 'organization': 'MED-EL Corporation'}, 'certainAgreement': {'otherDetails': 'The PI shall not publish until after the multi center publication, provided that the multi center publication is submitted within 12 months after conclusion of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 14, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Type B/Type C tympanogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Conductive hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Pain at implant site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders'}], 'seriousEvents': [{'term': 'Profound/total loss of residual hearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Electrode migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Electrode lead breakage', 'notes': 'Excess micro-movements caused by subject', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '29.8', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months post initial activation', 'description': 'CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.', 'unitOfMeasure': 'percentage of words correct (CUNY)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject lost residual hearing immediately following surgery and was unable to use EAS. This subject was tested with the cochlear implant alone and is not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '22.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months initial activation', 'description': 'CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.', 'unitOfMeasure': 'percentage of words correct (CUNY)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject lost residual hearing immediately after surgery and was unable to use EAS. The subject was testing in cochlear implant alone condition.'}, {'type': 'SECONDARY', 'title': 'Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '23.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post initial activation', 'description': 'CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.', 'unitOfMeasure': 'percentage of words correct (CNC)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.2', 'spread': '20.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post initial activation', 'description': 'A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.', 'unitOfMeasure': 'percentage of scoring change (APHAB)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 59 subjects completed the APHAB at preop and 12 months post activation.'}, {'type': 'SECONDARY', 'title': 'Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post initial activation', 'description': 'Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 59 subjects completed the HDSS at preop and 12 month post activation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Original Audiological Criteria', 'description': 'Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group.\n\nInclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Still undergoing follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 \\*110+\\*110+ \\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.\n\nElectric Acoustic System: Combination of a cochlear implant and a hearing aid'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of hearing loss', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': '6 participants withdrew before study completion, outcome measures are reported 67 participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2008-09-04', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2008-09-04', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-10', 'studyFirstPostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.', 'timeFrame': '12 months post initial activation', 'description': 'CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition', 'timeFrame': '12 months initial activation', 'description': 'CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.'}, {'measure': 'Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.', 'timeFrame': '12 months post initial activation', 'description': 'CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.'}, {'measure': 'Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.', 'timeFrame': '12 months post initial activation', 'description': 'A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.'}, {'measure': 'Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.', 'timeFrame': '12 months post initial activation', 'description': 'Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['sensorineural hearing loss', 'ski slope audiogram', 'electric acoustic stimulation'], 'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '17364328', 'type': 'BACKGROUND', 'citation': 'Skarzynski H, Lorens A, Piotrowska A, Anderson I. Preservation of low frequency hearing in partial deafness cochlear implantation (PDCI) using the round window surgical approach. Acta Otolaryngol. 2007 Jan;127(1):41-8. doi: 10.1080/00016480500488917.'}, {'pmid': '16864490', 'type': 'BACKGROUND', 'citation': 'Skarzynski H, Lorens A, Piotrowska A, Anderson I. Partial deafness cochlear implantation provides benefit to a new population of individuals with hearing loss. Acta Otolaryngol. 2006 Sep;126(9):934-40. doi: 10.1080/00016480600606632.'}, {'pmid': '15603395', 'type': 'BACKGROUND', 'citation': 'Skarzynski H, Lorens A, Piotrowska A. [New method of partial deafness treatment]. Otolaryngol Pol. 2004;58(4):811-6. Polish.'}, {'pmid': '12709676', 'type': 'BACKGROUND', 'citation': 'Skarzynski H, Lorens A, Piotrowska A. A new method of partial deafness treatment. Med Sci Monit. 2003 Apr;9(4):CS20-4.'}, {'pmid': '15724084', 'type': 'BACKGROUND', 'citation': 'Kiefer J, Pok M, Adunka O, Sturzebecher E, Baumgartner W, Schmidt M, Tillein J, Ye Q, Gstoettner W. Combined electric and acoustic stimulation of the auditory system: results of a clinical study. Audiol Neurootol. 2005 May-Jun;10(3):134-44. doi: 10.1159/000084023. Epub 2005 Feb 17.'}, {'pmid': '15141755', 'type': 'BACKGROUND', 'citation': 'Kiefer J, Gstoettner W, Baumgartner W, Pok SM, Tillein J, Ye Q, von Ilberg C. Conservation of low-frequency hearing in cochlear implantation. Acta Otolaryngol. 2004 Apr;124(3):272-80. doi: 10.1080/00016480310000755a.'}, {'pmid': '10545807', 'type': 'BACKGROUND', 'citation': 'von Ilberg C, Kiefer J, Tillein J, Pfenningdorff T, Hartmann R, Sturzebecher E, Klinke R. Electric-acoustic stimulation of the auditory system. New technology for severe hearing loss. ORL J Otorhinolaryngol Relat Spec. 1999 Nov-Dec;61(6):334-40. doi: 10.1159/000027695.'}, {'pmid': '17063011', 'type': 'BACKGROUND', 'citation': 'Gstoettner WK, Helbig S, Maier N, Kiefer J, Radeloff A, Adunka OF. Ipsilateral electric acoustic stimulation of the auditory system: results of long-term hearing preservation. Audiol Neurootol. 2006;11 Suppl 1:49-56. doi: 10.1159/000095614. Epub 2006 Oct 6.'}, {'pmid': '15224851', 'type': 'BACKGROUND', 'citation': 'Gstoettner W, Kiefer J, Baumgartner WD, Pok S, Peters S, Adunka O. Hearing preservation in cochlear implantation for electric acoustic stimulation. Acta Otolaryngol. 2004 May;124(4):348-52. doi: 10.1080/00016480410016432.'}, {'pmid': '19086194', 'type': 'RESULT', 'citation': "Gstoettner WK, van de Heyning P, O'Connor AF, Morera C, Sainz M, Vermeire K, Mcdonald S, Cavalle L, Helbig S, Valdecasas JG, Anderson I, Adunka OF. Electric acoustic stimulation of the auditory system: results of a multi-centre investigation. Acta Otolaryngol. 2008 Sep;128(9):968-75. doi: 10.1080/00016480701805471."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic processor designed to provide benefit in speech perception and sound quality to individuals with a sensorineural hearing loss with minimal changes in residual hearing. The acoustic component of the processor will aid residual acoustic hearing in low frequency ranges, while the cochlear implant and electric component of the processor will be used to electrically stimulate the auditory nerve across a wide range of frequencies necessary for speech perception.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Audiologic tests suggest a moderate sloping to severe/profound sensorineural hearing loss in the ear to be implanted. The non-implanted ear may fall outside of these criteria; however, threshold levels cannot be better than the indication criteria (for example, the non-implanted ear must be 60 dB or poorer at 1000 Hz, 70 dB or poorer at 2000-8000 Hz).\n* Pure-tone air-conduction threshold levels for the ear to be implanted shall fall at or within the following levels:\n\n 250 Hz - 500 Hz hearing loss less than or equal to 65 dB HL 750 Hz hearing loss less than or equal to 75 dB HL 1000-1500 Hz hearing loss less than or equal to 60 dBHL (ie. 60-110+ dB HL) 2000 Hz - 8000 Hz hearing loss less than or equal to 70 dB HL\n* Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 \\*110+ \\*110+ \\*110+ \\*110+ \\*90+\n* Pure-tone air-conduction thresholds for both ears are within 20 dB of each other at 250, 500 and 1000 Hz.\n* Air-bone gap at 500, 1000, 2000 and 4000 Hz should be \\<10 dB at two or more of these frequencies.\n* Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.\n* Normal middle ear anatomy and function (based on clinical assessment of tympanometry and acoustic reflex results). No prior middle ear surgery or history of postadolescent, chronic middle ear infections or inner ear disorders (i.e. vertigo or Meniere\'s syndrome).\n* No evidence that hearing loss origin is retrocochlear.\n* Current user of bilateral acoustic hearing aids for at least 3 months. Note: If the subject has not been a successful hearing aid user (i.e. improper fit, feedback and/or discomfort from high frequency amplification), he/she must complete a hearing aid trial in the ear to be implanted for at least 1 month. If the ear to be implanted is poorer than the contralateral ear, then the subject must complete a hearing aid trial in both ears for at least 1 month to ensure that he/she is tested in the best-aided condition.\n* Adults 18-70 years of age at time of implantation.\n* Persons who currently exhibit sufficient understanding and communicative skills to comprehend general conversation in an "oral/aural mode" through normal conversation channels.\n* English as primary language.\n* Appropriate motivation and expectation levels.\n\nExpanded Criteria:\n\nStudy Arm 2 candidates are those who meet the inclusion criteria listed above with the exception that:\n\nIn the ear to be implanted, the pure-tone air conduction threshold(s) at 250, 500, and/or 750 Hz will be greater than or equal to 0 dB HL and less than 10 dB HL, and/or In the ear to be implanted, the pure-tone air conduction threshold(s) at 1000 and/or 1500 Hz will be greater than or equal to 0 dB HL and less than 60 dB HL and/or In their best-aided condition, they score 51-60% on monosyllabic word scores.\n\nExclusion Criteria:\n\n* Conductive, retrocochlear or central auditory disorders.\n* Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years as demonstrated by serial audiograms. Note: In cases where 2-year documentation is missing, documentation of at least 18 months is necessary along with patient report of no fluctuation in the past 2 years. If 18-month data is unavailable, the patient must be monitored until 18-month data is available.\n* Any physical, psychological, or emotional disorder that would interfere with surgery or the ability to perform on test and rehabilitation procedures.\n* Developmental delays or organic brain dysfunction.\n* Physical or geographic limitations that may interfere with the completion of scheduled follow-up evaluations.\n* Skin or scalp conditions that could preclude magnetic attachment of the speech processor or use of the acoustic hearing aid.'}, 'identificationModule': {'nctId': 'NCT00747435', 'acronym': 'EAS', 'briefTitle': 'Safety and Effectiveness of the MED-EL Electric-Acoustic System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Med-El Corporation'}, 'officialTitle': 'The MED-EL EAS (Electric-Acoustic System) Using the PULSARCI100 FLEXeas / SONATATI100 FLEXeas and the DUET Speech Processor', 'orgStudyIdInfo': {'id': 'G040002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Original Audiological Criteria', 'description': 'Inclusion Criteria:\n\nPure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 \\*110+ \\*110+\\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.', 'interventionNames': ['Device: Electric Acoustic System']}, {'type': 'EXPERIMENTAL', 'label': 'Expanded Audiological Criteria', 'description': 'Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.\n\nFrequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 \\*110+ \\*110+\\*110+ \\*110+ \\*90+\n\nMinimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.\n\nStudy Arm 2 candidates are those who meet the inclusion criteria listed above with the exception that:\n\nIn the ear to be implanted, the pure-tone air conduction threshold(s) at 250, 500, and/or 750 Hz will be greater than or equal to 0 dB HL and less than 10 dB HL, and/or In the ear to be implanted, the pure-tone air conduction threshold(s) at 1000 and/or 1500 Hz will be greater than or equal to 0 dB HL and less than 60 dB HL and/or In their best-aided condition, they score 51-60% on monosyllabic word scores.', 'interventionNames': ['Device: Electric Acoustic System']}], 'interventions': [{'name': 'Electric Acoustic System', 'type': 'DEVICE', 'otherNames': ['EAS', 'Electric Acoustic Systems'], 'description': 'Combination of a cochlear implant and a hearing aid', 'armGroupLabels': ['Expanded Audiological Criteria', 'Original Audiological Criteria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94035', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Boys Town', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye & Ear', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospital', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Debra Tucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Christina Runge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}, {'name': 'Michael Ruckenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Hinrich Staecker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}, {'name': 'Peter Roland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Oliver Adunka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina Hospital'}, {'name': 'Ronald Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Eye and Ear'}, {'name': 'Richard Miyamoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}, {'name': 'Teresa Zwolan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Nikolas Blevins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Rodney Lusk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boys Town'}, {'name': 'Fred Telischi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Douglas Backous, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Medical Center'}, {'name': 'Frank Warren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Med-El Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}