Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-05 @ 5:38 PM
Study NCT ID:
NCT05377359
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lab Evaluation of Novel Hearing Aid Coupling Method
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': 'bilal.sheikh@sonova.com', 'phone': '2268083260', 'title': 'Bilal Sheikh, Research Audiologist', 'organization': 'Sonova'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were exposed to multiple interventions at once and had the ability to cycle through the various interventions (frequency curves). For this reason, adverse event data would have been collected per task and not intervention due to the quick exposure to multiple interventions. Adverse Event Data per participant was collected and is reported below. Streaming sound quality task - 60 minutes Situational preference task - 60 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Hearing Loss - Intake and Consent Form', 'description': 'Participants were recruited to join the study. During recruitment, participants would review and sign the consent form and a hearing test was completed. The same participants then moved on to the next two tasks.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants With Hearing Loss - Streaming Sound Quality Task', 'description': "All participants will be assessed under all interventions.\n\nRecordings of Hearing Aids with Open Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Closed Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 1: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 2: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants With Hearing Loss - Situational Preference Task', 'description': "All participants will be assessed under all interventions.\n\nRecordings of Hearing Aids with Novel State 1: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 2: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sound Quality Ratings While Streaming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sound Quality Ratings', 'description': 'All 20 participants were asked to listen to various recorded stimuli and were asked to rate preference for each stimuli based on certain sound quality attributes (overall impression, sharpness, and fullness).\n\nAll 4 interventions were implemented at once (as is the nature of the MUSHRA) and ratings were made at the same time.'}], 'classes': [{'title': 'Open Domes - Pop - Overall Impression', 'categories': [{'measurements': [{'value': '43.15', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '83'}]}]}, {'title': 'Vented Domes - Pop - Overall Impression', 'categories': [{'measurements': [{'value': '60.025', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '91'}]}]}, {'title': 'State 2 - Pop - Overall Impression', 'categories': [{'measurements': [{'value': '64.025', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '96'}]}]}, {'title': 'State 1 - Pop - Overall Impression', 'categories': [{'measurements': [{'value': '49.00', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '91'}]}]}, {'title': 'Open Domes - Speech - Overall Impression', 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '93'}]}]}, {'title': 'Vented Domes - Speech - Overall Impression', 'categories': [{'measurements': [{'value': '68.325', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '94'}]}]}, {'title': 'State 2 - Speech - Overall Impression', 'categories': [{'measurements': [{'value': '67.575', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '95'}]}]}, {'title': 'State 1 - Speech - Overall Impression', 'categories': [{'measurements': [{'value': '67.65', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '95'}]}]}, {'title': 'Open Domes - Classical - Overall Impression', 'categories': [{'measurements': [{'value': '68.525', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '94'}]}]}, {'title': 'Vented Domes - Classical - Overall Impression', 'categories': [{'measurements': [{'value': '71.775', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '94'}]}]}, {'title': 'State 2 - Classical - Overall Impression', 'categories': [{'measurements': [{'value': '65.725', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '92'}]}]}, {'title': 'State 1 - Classical - Overall Impression', 'categories': [{'measurements': [{'value': '61.525', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '92'}]}]}, {'title': 'Open Domes - Pop - Sharpness', 'categories': [{'measurements': [{'value': '68.175', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '93'}]}]}, {'title': 'Vented Domes - Pop - Sharpness', 'categories': [{'measurements': [{'value': '55.875', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '92'}]}]}, {'title': 'State 2 - Pop - Sharpness', 'categories': [{'measurements': [{'value': '49.725', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '92'}]}]}, {'title': 'State 1 - Pop - Sharpness', 'categories': [{'measurements': [{'value': '57.725', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '88'}]}]}, {'title': 'Open Domes - Classical - Sharpness', 'categories': [{'measurements': [{'value': '61.875', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '95'}]}]}, {'title': 'Vented Domes - Classical - Sharpness', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '95'}]}]}, {'title': 'State 2 - Classical - Sharpness', 'categories': [{'measurements': [{'value': '61.75', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '95'}]}]}, {'title': 'State 1 - Classical - Sharpness', 'categories': [{'measurements': [{'value': '60.275', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '92'}]}]}, {'title': 'Open Domes - Speech - Sharpness', 'categories': [{'measurements': [{'value': '56.95', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '93'}]}]}, {'title': 'Vented Domes - Speech - Sharpness', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '96'}]}]}, {'title': 'State 2 - Speech - Sharpness', 'categories': [{'measurements': [{'value': '54.525', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '95'}]}]}, {'title': 'State 1 - Speech - Sharpness', 'categories': [{'measurements': [{'value': '51.275', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '93'}]}]}, {'title': 'Open Domes - Pop - Fullness', 'categories': [{'measurements': [{'value': '45.525', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '90'}]}]}, {'title': 'Vented Domes - Pop - Fullness', 'categories': [{'measurements': [{'value': '61.525', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '95'}]}]}, {'title': 'State 2 - Pop - Fullness', 'categories': [{'measurements': [{'value': '66.55', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '91'}]}]}, {'title': 'State 1 - Pop - Fullness', 'categories': [{'measurements': [{'value': '51.725', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '91'}]}]}, {'title': 'Open Domes - Classical - Fullness', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '91'}]}]}, {'title': 'Vented Domes - Classical - Fullness', 'categories': [{'measurements': [{'value': '67.125', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '99'}]}]}, {'title': 'State 2 - Classical - Fullness', 'categories': [{'measurements': [{'value': '58.425', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '92'}]}]}, {'title': 'State 1 - Classical - Fullness', 'categories': [{'measurements': [{'value': '59.025', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '91'}]}]}, {'title': 'Open Domes - Speech - Fullness', 'categories': [{'measurements': [{'value': '57.875', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '93'}]}]}, {'title': 'Vented Domes - Speech - Fullness', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '94'}]}]}, {'title': 'State 2 - Speech - Fullness', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '93'}]}]}, {'title': 'State 1 - Speech - Fullness', 'categories': [{'measurements': [{'value': '59.875', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '94'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Hearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them.\n\nRatings will be made on a scale where 0 would the minimum value and 100 would be the maximum value.\n\nFullness: Higher scores indicate that participants found the recording to be fuller (thicker/richer sound). Higher scores indicate a better outcome.\n\nSharpness: Higher scores indicate that participants found the recording to be sharper (thinner/more shrill). Lower scores indicate a better outcome.\n\nOverall Impression: Higher scores indicate that participants had an increased preference towards the recording when compared to the other recordings. Higher scores indicate a better outcome.', 'unitOfMeasure': 'Units on a rating scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Situational Preference Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sound Quality Ratings - Situational Preference', 'description': 'All 20 participants were asked to listen to various recorded stimuli and were asked to rate overall sound quality\n\nAll 4 interventions were implemented at once (as is the nature of the MUSHRA) and ratings were made at the same time.'}], 'classes': [{'title': 'State 2 - Mic Off - Music - Stream', 'categories': [{'measurements': [{'value': '82.225', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '100'}]}]}, {'title': 'State 2 - Mic On - Music - Stream', 'categories': [{'measurements': [{'value': '23.125', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '70'}]}]}, {'title': 'State 1 - Mic Off - Music - Stream', 'categories': [{'measurements': [{'value': '50.35', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '99'}]}]}, {'title': 'State 1 - Mic On - Music - Stream', 'categories': [{'measurements': [{'value': '21.95', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '59'}]}]}, {'title': 'State 2 - Mic Off - Speech - Stream', 'categories': [{'measurements': [{'value': '84.225', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '98'}]}]}, {'title': 'State 2 - Mic On - Speech - Stream', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '72'}]}]}, {'title': 'State 1 - Mic Off - Speech - Stream', 'categories': [{'measurements': [{'value': '63.175', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '98'}]}]}, {'title': 'State 1 - Mic On - Speech - Stream', 'categories': [{'measurements': [{'value': '28.925', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '72'}]}]}, {'title': 'State 2 - Mic Off - Music - Noise', 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '99'}]}]}, {'title': 'State 2 - Mic On - Music - Noise', 'categories': [{'measurements': [{'value': '42.55', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90'}]}]}, {'title': 'State 1 - Mic Off - Music - Noise', 'categories': [{'measurements': [{'value': '45.90', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '79'}]}]}, {'title': 'State 1 - Mic On - Music - Noise', 'categories': [{'measurements': [{'value': '43.675', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '89'}]}]}, {'title': 'State 2 - Mic Off - Speech - Noise', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '97'}]}]}, {'title': 'State 2 - Mic On - Speech - Noise', 'categories': [{'measurements': [{'value': '41.675', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '87'}]}]}, {'title': 'State 1 - Mic Off - Speech - Noise', 'categories': [{'measurements': [{'value': '51.225', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '96'}]}]}, {'title': 'State 1 - Mic On - Speech - Noise', 'categories': [{'measurements': [{'value': '39.625', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 Minutes', 'description': 'Hearing aid recordings of different listening situations through different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will indicate preferences between different recordings.\n\nRatings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Higher scores indicate increased preferred sound quality.\n\nHigher scores will indicate that participants had an increased preference towards that recording when compared to the other recordings. In this measure, on', 'unitOfMeasure': 'Units on a rating scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a single arm study, where the arm is participants with hearing loss and who are exposed to multiple interventions (i.e., open domes, closed domes, state 1, and state 2) within-subjects design.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Hearing Loss', 'description': "Individuals with hearing loss that meet the candidacy to wear hearing aids with various coupling methods. All participants will be exposed to all interventions in a single session\n\nRecordings of Hearing Aids with Open Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Closed Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 1: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 2: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones."}], 'periods': [{'title': 'Intake and Consent Form Completion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Breaks Between Appointment 1 and 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Streaming Sound Quality Task', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Situational Preference Task', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Hearing Loss', 'description': "All participants will be assessed under all interventions.\n\nRecordings of Hearing Aids with Open Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Closed Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 1: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.\n\nRecordings of Hearing Aids with Novel State 2: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', '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': 'Hearing Thresholds', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '57.5'}]}]}], 'paramType': 'MEAN', 'description': "Hearing thresholds are measured via a hearing test. A hearing test is conducted by a licensed professional who is trained to conduct hearing tests and determine the severity of a participant's hearing loss. Depending on the configuration and severity of the hearing loss dictates if participants meet the requirements to join a clinical study. Hearing thresholds are measured across various frequencies and certain frequencies can differ significantly between participants. The average of four frequencies (500, 1000, 2000, and 4000 Hz (i.e., Pure Tone Average (PTA)) summarizes a participants loss.", 'unitOfMeasure': 'dB HL (decibel Hearing Loss)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hearing aid experience', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.73', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '27'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-30', 'size': 165692, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-13T10:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single cohort of participants will receive and be assessed in all treatment/intervention conditions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-05-11', 'resultsFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-10', 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sound Quality Ratings While Streaming', 'timeFrame': '60 minutes', 'description': 'Hearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them.\n\nRatings will be made on a scale where 0 would the minimum value and 100 would be the maximum value.\n\nFullness: Higher scores indicate that participants found the recording to be fuller (thicker/richer sound). Higher scores indicate a better outcome.\n\nSharpness: Higher scores indicate that participants found the recording to be sharper (thinner/more shrill). Lower scores indicate a better outcome.\n\nOverall Impression: Higher scores indicate that participants had an increased preference towards the recording when compared to the other recordings. Higher scores indicate a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Situational Preference Ratings', 'timeFrame': '60 Minutes', 'description': 'Hearing aid recordings of different listening situations through different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will indicate preferences between different recordings.\n\nRatings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Higher scores indicate increased preferred sound quality.\n\nHigher scores will indicate that participants had an increased preference towards that recording when compared to the other recordings. In this measure, on'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing Loss', 'Hearing Aids', 'Hearing Aid Receivers'], 'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '34369262', 'type': 'BACKGROUND', 'citation': 'Voss SC, Pichora-Fuller MK, Ishida I, Pereira A, Seiter J, El Guindi N, Kuehnel V, Qian J. Evaluating the benefit of hearing aids with motion-based beamformer adaptation in a real-world setup. Int J Audiol. 2022 Aug;61(8):642-654. doi: 10.1080/14992027.2021.1948120. Epub 2021 Aug 7.'}, {'pmid': '16515145', 'type': 'BACKGROUND', 'citation': 'Kuk F, Keenan D, Lau CC. Vent configurations on subjective and objective occlusion effect. J Am Acad Audiol. 2005 Oct;16(9):747-62. doi: 10.3766/jaaa.16.9.11.'}, {'pmid': '32196353', 'type': 'BACKGROUND', 'citation': 'Saleh HK, Folkeard P, Macpherson E, Scollie S. Adaptation of the Connected Speech Test: Rerecording and Passage Equivalency. Am J Audiol. 2020 Jun 8;29(2):259-264. doi: 10.1044/2019_AJA-19-00052. Epub 2020 Mar 20.'}, {'pmid': '26879562', 'type': 'BACKGROUND', 'citation': 'Winkler A, Latzel M, Holube I. Open Versus Closed Hearing-Aid Fittings: A Literature Review of Both Fitting Approaches. Trends Hear. 2016 Feb 15;20:2331216516631741. doi: 10.1177/2331216516631741.'}, {'pmid': '3678650', 'type': 'BACKGROUND', 'citation': 'Cox RM, Alexander GC, Gilmore C. Development of the Connected Speech Test (CST). Ear Hear. 1987 Oct;8(5 Suppl):119S-126S. doi: 10.1097/00003446-198710001-00010.'}, {'pmid': '3398490', 'type': 'BACKGROUND', 'citation': 'Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166.'}, {'pmid': '21278262', 'type': 'BACKGROUND', 'citation': 'Vasil-Dilaj KA, Cienkowski KM. The influence of receiver size on magnitude of acoustic and perceived measures of occlusion. Am J Audiol. 2011 Jun;20(1):61-8. doi: 10.1044/1059-0889(2010/09-0031). Epub 2011 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.', 'detailedDescription': 'An important decision in the fitting of hearing aids is the selection of the coupling method. Examples of coupling options include universal rubber domes and custom earmolds. When selecting a coupling method, the degree of venting must be considered.\n\nVenting refers to an opening in the coupling method to allow for the sound transmission from the tympanic membrane to the external environment. The degree of venting has a significant impact on the hearing aid user\'s experience. More closed (or more occluded) coupling means the vent is smaller or non-existent. Occluded fittings allow for more low-frequency amplification, which improves hearing aid performance like directionality, noise reduction and streaming sound quality. However, occluded fittings lead to complaints of the occlusion effect, in which users complain of their own voice as sounding "boomy" and can also lead to a build-up of pressure in the ear canal which users may find uncomfortable. To relieve the occlusion effect and pressure build-ups, more vented (sometimes called open) couplings can be used by allowing low-frequency sounds to leave the ear. Despite a degradation in hearing aid outcomes like directionality, noise reduction and streaming sound quality, open fits are typically preferred for speech quality and own-voice perception - at least for hearing aid users with milder losses and near-normal thresholds at low frequencies.\n\nThe fact that two coupling options are associated with two different outcomes means that hearing aid practitioners need to make an important trade-off. Either their patient will enjoy the full breadth of the hearing aid\'s signal processing potential (via a more occluded fit) or their patient will enjoy better own-voice perception and relief of air pressure in the ear canal(via a more open fit). A coupling method that allows for the best of both options is left to be desired.\n\nA recent development in coupling methods has allowed us to take advantage of both open and closed fittings in a single solution. More occluded coupling allows for more low-frequency amplification which improves hearing aid performance in areas such as directionality, noise reduction, and streaming sound quality. Whereas, open coupling options reduces complaints of the occlusion effect and is preferred for speech quality and own-voice perception by hearing aid users with milder losses. This novel coupling method will function as both an open and closed fitting depending on the environment the listener is in. State 1 is dedicated to loud environments where the listener can take advantage of noise management solutions and for streaming so they can enjoy better sound quality. State 2 is dedicated to quieter environments where the listener can enjoy better physical comfort and own-voice naturality.\n\nThis novel coupling method should theoretically exploit the benefits of both open and closed coupling methods. This study is designed to see how this novel coupling method compares to traditional domes and how this coupling method performs in various listening situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hearing aid candidate\n* Meets the fitting requirements for novel and traditional coupling options\n* Healthy outer ear - no visible congenital or traumatic deformity\n* Symmetrical hearing loss\n* No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz\n* Ability to answer questions and repeat sentences\n* No history of problematic tinnitus or pain/discomfort from loud sounds\n* No history of active drainage from the ears in the past 90 days\n* Informed consent as documented by signature.\n\nExclusion Criteria:\n\n* Limited mobility (not able to attend scheduled visits)\n* Inability to produce reliable hearing test results\n* History of active drainage from the ear in the previous 90 days\n* Abnormal appearance of the eardrum and ear canal\n* Known psychological problems.'}, 'identificationModule': {'nctId': 'NCT05377359', 'briefTitle': 'Lab Evaluation of Novel Hearing Aid Coupling Method', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Lab Evaluation of Novel Hearing Aid Coupling Method', 'orgStudyIdInfo': {'id': 'SRF-1082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with Hearing Loss', 'description': 'Individuals with hearing loss that meet the candidacy to wear hearing aids with various coupling methods. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.', 'interventionNames': ['Device: Recordings of Hearing Aids with Open Domes', 'Device: Recordings of Hearing Aids with Closed Domes', 'Device: Recordings of Hearing Aids with Novel State 1', 'Device: Recordings of Hearing Aids with Novel State 2']}], 'interventions': [{'name': 'Recordings of Hearing Aids with Open Domes', 'type': 'DEVICE', 'description': "Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.", 'armGroupLabels': ['Participants with Hearing Loss']}, {'name': 'Recordings of Hearing Aids with Closed Domes', 'type': 'DEVICE', 'description': "Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.", 'armGroupLabels': ['Participants with Hearing Loss']}, {'name': 'Recordings of Hearing Aids with Novel State 1', 'type': 'DEVICE', 'description': "Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.", 'armGroupLabels': ['Participants with Hearing Loss']}, {'name': 'Recordings of Hearing Aids with Novel State 2', 'type': 'DEVICE', 'description': "Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.", 'armGroupLabels': ['Participants with Hearing Loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6G1H1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Western University - National Centre for Audiology', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Jinyu Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sonova AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sonova Canada Inc.', 'class': 'INDUSTRY'}, {'name': 'Western University, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}