UnknownNot Applicable

SoundBite Hearing System 24 Month Multi Site Patient Use Study

United States75 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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

What they're measuring

Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire

Timeframe: 24 Months

Trial details

NCT IDNCT01807559

SponsorSonitus Medical Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-08

Contact for this trial

Linda Galow, MS

832-434-9730 linda@sonitusmedical.com

View on ClinicalTrials.gov More Single Sided Deafness trials