SoundBite Hearing System Long Term Multi Site Patient Use Study (NCT01445977) | Clinical Trial Compass
UnknownNot Applicable
SoundBite Hearing System Long Term Multi Site Patient Use Study
United States150 participantsStarted 2011-09
Plain-language summary
This study is designed to collect data about the SoundBite™ Hearing System to answer specific questions. The hearing system has been cleared for commercial distribution by the Food and Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what features and settings of this device provide the best hearing ability for people diagnosed with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are 18 years or older
* Clinical diagnosis of a Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (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)
* Patients diagnosed 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.
* At least two contiguous molar or premolar teeth with no untreated tooth decay. -Patients with tooth decay present are to first have restorations before being fitted for SoundBite
* Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
* No mobile teeth
* Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.
Exclusion Criteria:
* 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
* The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers.
* The SoundBite Hearing system is contraindicated for vulnerable populations that are unable to sue their hands such as paraplegics or others that are unable to comply with the warnings in the product…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aided Threshold Testing
Timeframe: 12 months
2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire