Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-14 @ 2:35 PM
Study NCT ID:
NCT05299892
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimizing Soft Speech Recognition in Children With Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D006312', 'term': 'Hearing Loss, Bilateral'}], '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': 'sara.neumann@heartsforhearing.org', 'phone': '405-548-4300', 'title': 'Sara Neumann, AuD', 'organization': 'Hearts For Hearing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Children With Hearing Loss', 'description': 'Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in unaided and aided condition.\n\nPhonak Audeo P or Naida P hearing aid: Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong"', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hearing Impaired Children Age 5-12', 'description': 'Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and tested in all four required conditions: unaided condition at 50 dB, and aided condition with SE off, on at moderate, and on at strong at 40 and 50 dB.'}], 'classes': [{'title': 'Percent words correct unaided, in quiet (50 dBA)', 'categories': [{'measurements': [{'value': '6.06', 'spread': '9.73', 'groupId': 'OG000'}]}]}, {'title': 'Percent words correct aided with SE off, in quiet ( 40 dBA)', 'categories': [{'measurements': [{'value': '53.7', 'spread': '13.02', 'groupId': 'OG000'}]}]}, {'title': 'Percent words correct, aided with SE moderate, in quiet (40 dBA)', 'categories': [{'measurements': [{'value': '66.61', 'spread': '11.92', 'groupId': 'OG000'}]}]}, {'title': 'Percent words correct, aided with SE strong, in quiet (40 dBA)', 'categories': [{'measurements': [{'value': '69.7', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Percent words correct, aided SE off, in quiet (50 dBA)', 'categories': [{'measurements': [{'value': '74.7', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Percent words correct, aided SE moderate, in quiet (50 dBA)', 'categories': [{'measurements': [{'value': '81.76', 'spread': '6.78', 'groupId': 'OG000'}]}]}, {'title': 'Percent words correct, aided SE strong, in quiet (50 dBA)', 'categories': [{'measurements': [{'value': '83.76', 'spread': '6.87', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.005', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.46153', 'ciLowerLimit': '1.79', 'ciUpperLimit': '12.99', 'groupDescription': "An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.00961', 'ciLowerLimit': '3.91', 'ciUpperLimit': '15.11', 'groupDescription': "An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of 1 day study', 'description': 'One word list of 25 words is presented at 50 dB (quiet conditions) through a front speaker. The percent correctly repeated words are calculated and a higher score indicates better speech perception. The participants completed this task without hearing aids. Data was collected on both age groups, but analysis was completed only on the entire group as a whole. Age effects were not tested.', 'unitOfMeasure': 'percentage of correctly repeated words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hearing impaired participants who completed all required testing conditions: 1) word recognition unaided, 2)word recognition at 40 dB input with SE off, 3) word recognition at 40 dB input with SE on moderate setting, 4) word recognition at 40 dB input with SE on strong setting, 5) word recognition at 50 dB input with SE off, 6) word recognition with at 50 dB input with SE on moderate setting, and 7) word recognition with 50 dB input with SE on strong setting.'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings of Speech Enhancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hearing Impaired Users Age 5 -12', 'description': 'Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and tested in all required conditions: unaided condition, and aided condition with SE off, on at moderate, and on at strong and were able to answer all three questions.'}], 'classes': [{'title': 'SE Moderate sounds better than SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'SE Moderate sounds the same as SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'SE Off sounds better than SE Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'SE Moderate is more comfortable than SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'SE Moderate is the same comfort as SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'SE Off is more comfortable than SE Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Prefer SE Moderate to SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Prefer both SE Off and SE Moderate the same', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Prefer SE Off to SE Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'SE Strong sounds better than SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'SE Strong sounds the same as SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'SE Off sounds better than SE Strong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'SE Strong is more comfortable than SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'SE Strong is the same comfort as SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'SE Off is more comfortable than SE Strong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Prefer SE Strong to SE Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Prefer both SE Strong and SE Off the same', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Prefer SE Off to SE Strong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of 1 day study', 'description': 'Participants will listen to a sound sample of looped sentences overlaid with low-level transient noise with the Speech Enhancer at different settings (off, moderate, strong) and rate their preference. An A/B comparison will be used to compare Speech Enhancer Off vs. Speech Enhancer Moderate, and Speech Enhancer Off vs. Speech Enhancer Strong. Participants answered three questions: 1) Which sounds better?, 2) Which is more comfortable?, and 3) Which do you prefer? Results will be reported as qualitative data and no statistical analysis will take place.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the testing requirements and were able to provide answers to all three questions: 1) Which sounds better? 2) Which is more comfortable? and 3) Which do you prefer? Data was collected on both age groups, but was analysis was completed only on entire group as a whole. Age effects were not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hearing Impaired Users', 'description': 'Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and complete all testing requirements (unaided, aided with SE off, aided with SE on moderate, and aided with SE on strong).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Children With Hearing Loss, Age 5-12', 'description': 'Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in all four required conditions: Unaided, Aided with SE off, Aided with SE moderate, and Aided with SE strong.\n\nPhonak Audeo P or Naida P hearing aid: Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong"'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', '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': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who were enrolled in study and were fit with the study hearing aids.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-14', 'size': 361174, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-27T17:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants will be "blind" as to whether the Speech Enhancer feature is activated or deactivated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One group of participants will be assessed unaided and aided with Phonak Audeo P or Phonak Naida P hearing aids with Speech Enhancer "off", "on at moderate", and "on at strong" settings.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2022-03-01', 'resultsFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-24', 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists', 'timeFrame': 'Day 1 of 1 day study', 'description': 'One word list of 25 words is presented at 50 dB (quiet conditions) through a front speaker. The percent correctly repeated words are calculated and a higher score indicates better speech perception. The participants completed this task without hearing aids. Data was collected on both age groups, but analysis was completed only on the entire group as a whole. Age effects were not tested.'}], 'secondaryOutcomes': [{'measure': 'Subjective Ratings of Speech Enhancer', 'timeFrame': 'Day 1 of 1 day study', 'description': 'Participants will listen to a sound sample of looped sentences overlaid with low-level transient noise with the Speech Enhancer at different settings (off, moderate, strong) and rate their preference. An A/B comparison will be used to compare Speech Enhancer Off vs. Speech Enhancer Moderate, and Speech Enhancer Off vs. Speech Enhancer Strong. Participants answered three questions: 1) Which sounds better?, 2) Which is more comfortable?, and 3) Which do you prefer? Results will be reported as qualitative data and no statistical analysis will take place.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural', 'Hearing Loss, Bilateral']}, 'descriptionModule': {'briefSummary': 'Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple talkers at a distance to capitalize on overhearing. A recent investigation by Jace Wolfe and colleagues showed that, even when aided, children with hearing loss had significantly poorer speech recognition at 40, 50 and 60 dBA compared to children with normal hearing. Furthermore, they showed that increasing hearing aid gain for very low-level inputs produced a statistically significant improvement in syllable-final plural recognition and a non-significant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document low-level speech recognition ability of children with hearing loss as well as the potential benefit or detriment of increasing hearing aid gain for low-level inputs. A novel hearing aid technology known as Soft Speech Enhancer has been shown improve low-level speech perception in adults with hearing loss; however, the effect of Speech Enhancer on speech recognition in children is not yet known and will be evaluated.', 'detailedDescription': 'The primary objective of this study is to evaluate whether soft speech recognition in quiet is significantly improved with Speech Enhancer (SE) "on" at the default setting (moderate) compared to Speech Enhancer "off" in children with moderate (N3) to severe (N5) hearing loss. There are several secondary objectives: 1) To evaluate the main effects of age and Speech Enhancer strength, and potential interaction on speech recognition and comfort in children with moderate to severe hearing loss. 2) To demonstrate that hearing aids compensate for hearing loss in children.\n\nThis confirmatory clinical investigation will be executed at Hearts for Hearing. It is a single-group, single blind intervention study with each participant serving as his or her own control. However, in certain conditions participant blinding is not feasible (i.e., aided versus unaided performance). The outcome measures being assessed include: speech recognition in quiet with Consonant-Nucleus-Consonant (CNC) words, and comfort ratings using a Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) procedure and looped sentences overlaid with low-level transient noise.\n\nFour different hearing aid conditions will be assessed in this clinical investigation: unaided (no amplification), aided with SE "off", aided with SE "moderate", aided with SE "strong". For the unaided or no treatment condition no hearing aids will be worn. For aided conditions, experienced hearing aid users will be fit binaurally with investigational devices matching their personal device form factor connected to their personal acoustic coupling (e.g., earmold). Using the Audioscan Verifit 2, probe microphone measurements will be conducted to match DSL 5.0 pediatric quiet and noise targets. Three distinct programs will be created, each with a different SE strength.\n\nHearing aid program order (speech enhancer settings) will be randomized for all testing conditions except for CNC at 50 dBA Quiet with SE Off; that condition is administered first to establish candidacy for further testing. A randomized list of SE settings was generated for all participants for the remaining conditions.\n\nTesting will be completed in a double-walled sound booth with calibrated equipment. Recorded stimuli will be presented through loudspeakers (Sony CFD-ZW755) from clinical audiometers (Grayson Stadler Standard) or Dell computers using the Arizona State University Speech Recognition Program, Windows Media Player and Adobe Audition. Speech stimuli will be presented from a loudspeaker located at 0 degrees azimuth (directly in front).\n\nSpeech recognition results will be compared to determine the effect of amplification on accuracy scores as well as the influence of speech enhancer on behaviorally measured benefit and subjectively-derived listening preference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* native English speakers who communicate verbally\n* no known speech language disorders, cognitive or learning issues\n* experienced hearing aid users (\\> 6 months use)\n* "full-time" hearing aid users (i.e., wear on a daily basis)\n* CNC word scores of 30% or better at 50dBA in quiet with SE "off"\n\nExclusion Criteria:\n\n* new hearing aid users\n* inconsistent hearing aid users\n* \\<4 years or \\>12 years of age\n* non-native English speaker who communicates verbally\n* known cognitive/ learning issues or speech language disorder\n* CNC word scores \\< 30% correct presented at 50dBA in quiet with SE "off"'}, 'identificationModule': {'nctId': 'NCT05299892', 'acronym': 'SoftSpeech', 'briefTitle': 'Optimizing Soft Speech Recognition in Children With Hearing Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Optimizing Soft Speech Recognition in Children With Hearing Loss', 'orgStudyIdInfo': {'id': '458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children with Hearing Loss', 'description': 'Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in unaided and aided condition.', 'interventionNames': ['Device: Phonak Audeo P or Naida P hearing aid']}], 'interventions': [{'name': 'Phonak Audeo P or Naida P hearing aid', 'type': 'DEVICE', 'description': 'Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong"', 'armGroupLabels': ['Children with Hearing Loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hearts for Hearing', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hearts for Hearing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}