TINNITUS THERAPY SYSTEM ANM T30 CR

{0}------------------------------------------------ K112752 DEC 1 6 2011 #### 510(k) Summary 5 | Company Name:<br>Address: | ANM Adaptive Neuromodulation GmbH<br>Im Mediapark 6d<br>50670 Cologne<br>Germany | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Telephone:<br>FAX: | +49 (0)221 454-6300 Ext. 6340<br>+49 (0)221 454-6302 | | Contact person: | Dr. Ingrid Rohm<br>Quality & Regulatory Manager | | Date summary prepared: | September 9, 2011 | | Classification Name/<br>Common Name: | Tinnitus Masker | | Trade Name: | ANM T30 CR® Tinnitus Therapy System | | Product Code: | KLW | | Device Classification: | Class II | | Predicate Devices: | Neuromonics Tinnitus Treatment System, K043274<br>(Neuromonics PTY Ltd.)<br>TinniTech ANMP System, K030791 (Tinnitech Ltd.) | ## Device Description: The ANM T30 CR® is a computer-controlled system for tinnitus therapy is provided to the patient by individualized, ambient acoustic tones. The system consists of four components: ANM T30 CR® Programmer (computer) including the tinnitus analysis software ANM T30 CR® SW: The ANM T30 CR® Software is used to measure the tinnitus, adjust the individual therapeutic stimulation signals and program the patient device (ANM T30 CR® Stimulator). ## ANM T30 CR® Patient Console: The ANM T30 CR® Patient Console is connected to the ANM T30 CR® Programmer and is used by the patient to adjust the parameters specific to his/her tinnitus (frequency and loudness) during tinnitus measurement and stimulation signal adjustment. # ANM T30 CR® Stimulator (patient device): The stimulator is used by the patient for the application of the therapeutic stimulation signal. It has a rechargeable battery for the energy supply and electronic components to generate the stimulation signal. {1}------------------------------------------------ ## ANM T30 CR® Earphones: The ANM T30 CR® Earphones are to be connected either to the ANMT30 CR® Patient Console to measure the tinnitus and adjust the stimulation signal or to the ANM T30 CR® Stimulator to apply the stimulation signal. Patient contact parts are manufactured from materials that meet the ISO-10993 biocompatibility requirement contact with intact skin, as tested by their suppliers. The ANM T30 CR® Tinnitus Therapy System meets the applicable general electrical safety requirements of IEC 60601 1, and the requirements of IEC 60601-1-2. ## Intended Use: The ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system. The ANM T30 CR® Stimulator is a patient device for home use. The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment. Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age. Table 5.1: Comparison to Predicate Device: | | ANM T30 CR® System | Neuromonics Tinnitus Treatment System | TinniTech ANMP System | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The ANM T30 CR®<br>Tinnitus Therapy<br>System is intended to<br>provide relief from the<br>disturbance of tinnitus<br>while using the system,<br>and with regular use<br>(over several months)<br>may provide relief to<br>the patient when not<br>using the system.<br>The ANM T30 CR®<br>Stimulator is a patient<br>device for home use.<br>The ANM T30 CR®<br>Stimulator is fitted and<br>programmed by a<br>qualified healthcare<br>professional familiar<br>with tinnitus<br>treatment.<br>Stimulation needs to be<br>applied for several<br>hours a day over a<br>period of weeks or<br>months.<br>The target population is<br>adults over 18 years of<br>age. | The Neuromonics Tinnitus<br>Treatment System is<br>intended to provide relief<br>from the disturbance of<br>tinnitus while using the<br>system, and with regular<br>use (over several months)<br>may provide relief to the<br>patient when not using the<br>system.<br>The Neuromonics Tinnitus<br>Treatment System is<br>intended to interact and<br>intermittently interact with<br>the patients tinnitus as part<br>of a tinnitus management<br>program. The addition of<br>the music is to aid the<br>promotion of relaxation<br>during the tinnitus<br>interaction process.<br>The initial hearing and<br>tinnitus tests are conducted<br>by a qualified audiologist<br>familiar with the treatment<br>of tinnitus; the subsequent<br>management of the<br>treatment is carried out by<br>an appropriate healthcare | The ANMP System is<br>intended to completely<br>mask and intermittently<br>mask tinnitus as part of a<br>tinnitus management<br>program. The addition of<br>the music is to aid the<br>promotion of relaxation<br>during the tinnitus masking<br>process.<br>The initial hearing and<br>tinnitus tests are conducted<br>by a qualified audiologist<br>familiar with the treatment<br>of tinnitus; the subsequent<br>management of the<br>treatment is carried out by<br>an appropriate healthcare<br>professional.<br>The target population for<br>the device is adults (18<br>years and over) who<br>present with tinnitus that<br>may or may not be<br>accompanied with hearing<br>loss at the higher<br>frequencies and who are<br>participating in a tinnitus | | | ANM T30 CR® System | Neuromonics Tinnitus Treatment System | TinniTech ANMP System | | | | professional. | management program. | | | | The target population for the device is adults (18 years and over) who present with tinnitus that may or may not be accompanied with hearing loss at the higher frequencies and who are participating in a tinnitus management program. | | | Physical dimensions | ANM T30 CR® Stimulator (1.85" x 1.65" x 0.91") with preprogrammed auditory stimuli delivered through earphones | iPod-like device (4.06" x 2.32" x 0.71") with prerecorded audio stimuli delivered through headphones | The Philips eXanium 401 mini MP3 mini CD player with earphones is supplied by TinniTech<br>Size:<br>3.6" x 4.7" x 1.1" (LxHxD) | | Maximum Output Characteristics | Maximum output is 80 dB(A) (software-controlled).<br>This maximum can be exceeded only with the consent of a qualified healthcare professional to 115 dB(A). As this maximum output exceeds the OSHA (Standard 1910.95) 8 hour time weighted average for the occupational workplace, warnings are included in the User Manual | Fixed at 80 dB SPL | The maximum output from the earphones could exceed 85 dBA, the OSHA (Standard 29CFR 1910.95) 8 hour time weighted average for the occupational workplace, and therefore a warning about setting the player volume setting at a comfortable (safe) level is included in the User's Manual and on the player | | Frequency Range | 90 Hz - 13 kHz | 100 Hz - 12.5 kHz | 20 Hz - 20 KHz | | Audio Signal Technology | Digital | Digital | Digital | | Medium | Flash Memory | SD Memory Card | Two mini CDs | | Energy used | 2.4V, 2 x rechargeable Ni-MH button, 1.2V | Lithium polymer, output 6V | The supplied mini disc player, the Philips eXpanium 401 operates from either one AA cell or a 110 VAC mains adapter provided with the player | | Transducer (headphones type) | Use only earphones supplied with the ANM T30 CR® Tinnitus Therapy System. The | Use only earphones supplied with the Neuromonics device. Other earphones may not | Use the earphones provided with the mini disc player | | | ANM T30 CR® System | Neuromonics Tinnitus<br>Treatment System | TinniTech ANMP System | | | stimulation sequence<br>program has been<br>acoustically aligned<br>specifically for use with<br>these earphones | sounds that are essential<br>for treatment | | | Where used | Home use under the<br>supervision of a<br>qualified healthcare<br>professional | Home use under the<br>supervision of a qualified<br>clinician | Home use under the<br>management of an<br>appropriate qualified<br>healthcare professional | | Safety | Avoid using the ANM<br>T30 CR® Tinnitus<br>Therapy System while<br>driving or other<br>activities that require<br>the patient's full<br>attention | Avoid using the<br>Neuromonics device while<br>driving, cycling, or while<br>performing any other<br>activity that requires the<br>patient's full attention | The ANMP therapy should<br>never be undertaken when<br>tinnitus masking sounds<br>might prevent the patient<br>from hearing cues or<br>warnings of likely harm or<br>danger | {2}------------------------------------------------ . {3}------------------------------------------------ ## Summary of performance data: Nonclinical verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the device. Testing involved verification of software requirement specifications from risk analysis. The testing shows that the ANM T30 CR® System is as safe, as effective and performs as well as or better than the predicate devices identified in the above Comparison Table. ## Risks to health With a maximum output of 115 dB(A) the ANM T30 CR® Stimulator could exceed the occupational workplace OSHA standard 29 CFR 1910.95. To avoid possible hearing damage the health care professional only can program the stimulator to allow for acoustic signals above 80 dB(A) for use by tinnitus patients who suffer from impaired hearing. The User's Manual carries precautions to reduce the acoustic volume or stop the treatment if the auditory stimulation volume is uncomfortable. It also states that stimulation should not been done when undisturbed attention is required. ## Hearing Healthcare Professional Diagnosis The sale and fitting of the ANM T30 CR® system will only be conducted through a Hearing Healthcare Professional. # Benefits Supported by appropriate counselling and/or tinnitus therapy, relief from tinnitus symptoms may be experienced by using the ANM T30 CR® Stimulator. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ANM Adaptive Neuromodulation GmbH c/o Dr. Ingrid Rohm Quality & Regulatory Manager Im Mediapark 6d 50670 Cologne Germany DEC 1 6 2011 Re: K112752 Trade/Device Name: ANM T30 CR® Tinnitus Therapy System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: September 9, 2011 Received: September 21, 2011 Dear Dr. Rohm: 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. {5}------------------------------------------------ Page 2 - Dr. Ingrid Rohm 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm. Sincerely vours. Melvina R. Evdelman, M.D. 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 Enclosure {6}------------------------------------------------ K//2+52 #### Indications for Use 4 510(k) Number (if known): ANM T30 CR® Tinnitus Therapy System Device Name: Indications For Use: The ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system. The ANM T30 CR® Stimulator is a patient device for home use. The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment. Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age. Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of Anne K. Kane Ph.D. hsion Sign-Off) ision Sign-On) sion of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number