SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL

{0}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ #### JUN 2 1 2011 5. 510(K) SUMMARY This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: June 21, 2011 510(k) number: #### Applicant Information: Sonitus Medical, Inc. 1825 S. Grant St., Suite 350 San Mateo. CA 94402 Telephone: (650) 838-0325 Fax: (650) 838-0326 #### Contact Person Robert J. Chin Phone Number: (650) 593-5225 E-mail: rjchin@pacbell.net #### Device Information: Trade Name: Classification: Classification Name: SoundBite™ Hearing System by Sonitus Medical Class II Hearing Aid, Bone Conduction (Regulation: 21CFR; 874.3300, Product Code: LXB) #### Physical Description: The SoundBite Hearing System by Sonitus Medical consists of two main components; a behind the ear (BTE) microphone unit and an in the mouth (ITM) hearing device. Accessories include a system charger and programming software. The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the hearing device worn in the mouth. The ITM hearing device in turn creates imperceptible vibrations using a piezoelectric actuator that are sent via the teeth, through the skull bones, and ultimately to the cochleae. #### Indications for Use: The SoundBite Hearing System is intended for patients 18 years and older with the following indications: - . Patients with 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 average bone-conduction . hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL. Sonitus Medical Inc. {1}------------------------------------------------ and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen Additionally, use of SoundBite is intended for patients with: - 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. ## Contraindications: - The SoundBite Hearing System and all portions of it are contraindicated for use in an ● MR! 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. ## Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the SoundBite Hearing System (K100649) and Cochlear Baha (K090720). ### Basis for the Submission: The basis for the submission is for an expanded Indication for Use of the SoundBite Hearing System which was previously cleared for use in patients with single-sided deafness (K100649). The Indication for Use has been expanded to include patients with conductive hearing loss. ### Conformance to Standards: The SoundBite Hearing System complies with applicable portions of the following standards: Electrical Safety, EMC and wireless - IEC/EN 60601-1 (Medical Electrical Equipment Part 1: General requirements for basic . safety and essential performance) - IEC/EN 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance) - . IEC/EN 60601-1-4 (Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems) - IEC 60529 (Classification of degrees of protection provided by enclosures) . - EN 301-489 Parts 1 and 3 (Electromagnetic compatibility and Radio spectrum Matters . (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; - EN 300-330 Parts 1 and 2 (Electromagnetic compatibility and Radio spectrum Matters . (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz) - IEEE C95.1 (IEEE Standard for Safety Levels with Respect to Human Exposure to . Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz) Sonitus Medical Inc. {2}------------------------------------------------ ### Biocompatibility and Cleaning - ISO 10993-1 (Biological Evaluation of Medical Devices Part 1: Evaluation and testing) . - ASTM E 2314-03 (Standard Test Method for Determination of Effectiveness of Cleaning . Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)) ### Packaging and Labeling - ANSI/AAMI/ISO 15223-1 (Medical devices Symbols to be used with medical device . labels, labeling, and information to be supplied - Part 1: General requirements) - IEC 80416-3 (Basic principles for graphical symbols for use on equipment Part 3: . Guidelines for the application of graphical symbols) - . ASTM F 2503-08 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment) - EN 980:2008 (Device Labeling Guidance) . - ASTM D4169-09 (Performance testing of shipping containers and systems) . ### Quality Systems - 21 CFR 820 (Quality System Regulation) . - . ISO 13485 (Medical devices - Quality management systems, requirements for regulatory purposes) - ISO 14971 (Medical devices Application of risk management to medical devices) . ### Substantial Equivalence Discussion: The SoundBite Hearing System is substantially equivalent to the identified predicates in both safety and effectiveness as follows: ### In terms of Safety; - . The SoundBite Hearing System has already been FDA cleared for the treatment of single sided deafness (K100649). - Because the predicate SoundBite Hearing System has been proven safe for the . treatment of SSD, it is therefore also safe for the treatment of conductive hearing loss because the form factor and technological characteristics to be used for this new indication are identical to the form factor and technological characteristics used for treating SSD. ### In terms of effectiveness; - . The SoundBite Hearing System has been shown to be substantially equivalent to Baha for the treatment of SSD (K100649). - . Baha is indicated for the treatment of conductive hearing loss (K090720) using the same form factor and technological characteristics that was used for the treatment of SSD. - . Both Baha and SoundBite use an equivalent mechanism of action: the principle of bone conduction to transmit sound via bone to the cochlea. Sonitus Medical Inc. {3}------------------------------------------------ - Because SoundBite has been proven effective for the treatment of SSD a condition in . which only one cochlea functions normally and the other does not work at all - SoundBite must be no less effective for treating conductive hearing loss, a condition in which both cochleae function normally. #### Summary: Based on the intended use, product, and substantial equivalence discussion provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Sonitus Medical Inc. c/o Robert J. Chin, Ph.D. Regulatory Consultant 1825 S. Grant St., Suite 350 San Mateo, CA 94402 JUN 2 1 2011 Re: K110831 Trade/Device Name: SoundBite Hearing System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Class II Product Code: LXB Dated: March 23, 2011 Received: March 25, 2011 Dear Dr. Chin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {5}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Ruhm ·Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ SoundBite™ Hearing System by Sonitus Medical 510(k) Notification # 4. INDICATIONS FOR USE STATEMENT 510(k) Number (if known): SoundBite™ Hearing System by Sonitus Medical Device Name: Indications for Use: The SoundBite Hearing System is intended for patients 18 years and older with the following indications: - Patients with 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 average bone-conduction . hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL. Additionally, use of SoundBite is intended for patients with: - . 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. Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Vorabanding (Division Sign-Off) Division of Ophthalmic, Neurological and Ea Nose and Throat Devices 510(k) Number