SoundBite Hearing System 24 Month Multi Site Patient Use Study

Sonitus Medical Inc7 sites in 1 country75 target enrollmentMarch 2013

ConditionsSingle Sided Deafness Conductive Hearing Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Single Sided Deafness
Sponsor: Sonitus Medical Inc
Enrollment: 75
Locations: 7
Primary Endpoint: Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

August 2014

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sonitus Medical Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Additionally, subjects must meet one of the two criteria for hearing loss:
•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.
•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.

Exclusion Criteria

•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:
•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.
•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
•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 use their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.

Outcomes

Primary Outcomes

Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire

Time Frame: 24 Months

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.