Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT01807559
Status:
UNKNOWN
Last Update Posted:
2013-05-03
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SoundBite Hearing System 24 Month Multi Site Patient Use Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006314', 'term': 'Hearing Loss, Conductive'}, {'id': 'D046088', 'term': 'Hearing Loss, Unilateral'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-02', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Single Sided Deafness Questionnaire', 'timeFrame': '24 Months', 'description': 'This questionnaire assesses quality of life outcomes.'}], 'primaryOutcomes': [{'measure': 'Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire', 'timeFrame': '24 Months', 'description': 'Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A- New Formate, Hearing Aid Research Lab, University of Memphis, 1994) score at 24 months compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Aided Threshold Testing', 'timeFrame': '24 Months', 'description': 'Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Single Sided Deafness', 'Conductive Hearing Loss', 'Unilateral Hearing Loss', 'SSD'], 'conditions': ['Single Sided Deafness', 'Conductive Hearing Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://soundbitehearing.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All trial subjects are individuals who are already currently using SoundBite Hearing System for treatment of their SSD or CHL and were enrolled in the SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN0006). Participants are willing to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who previously were enrolled in SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN006) and completed the 12 month study visit.\n* Additionally, subjects must meet one of the two criteria for hearing loss:\n\n 1. Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.\n\n OR\n 2. Conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL.\n\nExclusion Criteria:\n\n* Subjects that do not meet one of the two the audiometric criteria as measured on the audiogram for the 12 month study appointment for Protocol CLN006:\n\n 1. A moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or -SSD‖). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.\n 2. Patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL\n\n * The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI exposure\n * The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers.\n * The SoundBite Hearing system is contraindicated for vulnerable populations that are unable to use their hands such as paraplegics or others that are unable to comply with the warnings in the product\'s labeling.'}, 'identificationModule': {'nctId': 'NCT01807559', 'briefTitle': 'SoundBite Hearing System 24 Month Multi Site Patient Use Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonitus Medical Inc'}, 'officialTitle': 'SoundBite Hearing System 24 Month Multi Site Patient Use Study', 'orgStudyIdInfo': {'id': 'CLN009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SoundBite Hearing System', 'type': 'DEVICE', 'description': 'The Sonitus Medical SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for the treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus Medical SoundBite Hearing System consists of an In-the-Mouth (ITM) component, an external microphone component worn behind the ear (BTE), a calibration interface cable and PC-controlled software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this study is multi-site observational study is to asses the long-term patient use of the Sonitus Medical SoundBite Hearing System.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Hernanadez, AuD', 'role': 'CONTACT', 'email': 'audiology@arizonaear.com', 'phone': '602-307-9919'}, {'name': 'Mark Syms, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona Ear Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Mattson, AuD', 'role': 'CONTACT', 'phone': '858-909-0770'}, {'name': 'Ritvik Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'California Hearing and Balance', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cheryl Tanita, AuD', 'role': 'CONTACT', 'email': 'ctanita@eardoctor.org', 'phone': '949-631-4327'}, {'name': 'Jack Shohet, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shohet Ear Associates', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '20006', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Lazaro, AuD', 'role': 'CONTACT', 'email': 'rlazaro@mfa.gwu.edu', 'phone': '202-741-3275'}, {'name': 'Ashkan Monfared, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The George Washington University-Department of Otolaryngology', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Clark, AuD', 'role': 'CONTACT', 'phone': '813-558-1477'}, {'name': 'Jeffrey Clark, AuD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Physicians Choice Hearing and Balance', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robyn Shanley, PhD', 'role': 'CONTACT', 'email': 'RobynS@earmedicalgroup.com', 'phone': '210-614-6070'}, {'name': 'Charles Syms, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ear Medical Group', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diane Tyler, RN', 'role': 'CONTACT', 'email': 'diane.tyler@hsc.utah.edu', 'phone': '801-587-4824'}, {'name': 'Richard Gurgel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Health Science Center (University of Utah Hospital)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Linda Galow, MS', 'role': 'CONTACT', 'email': 'linda@sonitusmedical.com', 'phone': '832-434-9730'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonitus Medical Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}