SoundBite Hearing System 24 Month Multi Site Patient Use Study

Conductive Hearing Loss Clinical Trial

Official title:

SoundBite Hearing System 24 Month Multi Site Patient Use Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01807559
• Other study ID #: CLN009
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2013
• Last updated: May 2, 2013
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2013
• Source: Sonitus Medical Inc
• Contact: Linda Galow, MS
• Phone: 832-434-9730
• Email: linda[@]sonitusmedical.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

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.

OR

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.

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:

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.

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

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Single Sided Deafness

Intervention

Device:
• SoundBite Hearing System
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.

Locations

Country	Name	City	State
United States	California Hearing and Balance	La Jolla	California
United States	Shohet Ear Associates	Newport Beach	California
United States	Arizona Ear Center	Phoenix	Arizona
United States	University Health Science Center (University of Utah Hospital)	Salt Lake City	Utah
United States	Ear Medical Group	San Antonio	Texas
United States	Physicians Choice Hearing and Balance	Tampa	Florida
United States	The George Washington University-Department of Otolaryngology	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sonitus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single Sided Deafness Questionnaire	This questionnaire assesses quality of life outcomes.	24 Months	No
Primary	Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire	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.	24 Months	No
Secondary	Aided Threshold Testing	Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System	24 Months	No

External Links

•   Link