1. Snoring and Obstructive Sleep Apnea (OSA) Devices Dental Devices Branch Division of Anesthesiology, General Hospital, Infection Control and Dental Devices October 6, 2004 Kevin Mulry, D.D.S., M.P.H.

2. Scope of Dental Devices for Panel Discussion Includes: Intraoral devices –fitted over teeth –removable Does not include: Implantable devices Surgical devices CPAP Diagnostic Devices

3. Regulatory History Panel Meeting in 1997 for classification –Panel recommendation - Class II Special Control Sponsors need to submit a 510(k) (premarket notification) Published a Class II Special Controls Guidance Document NSE decision for OTC device Some sponsors have requested that these devices be made available OTC. That is the reason we are asking for your input today as to what data sponsors should submit to provide reasonable assurance of safety and effectiveness for OTC use.

4. Regulation 21CFR 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction.

5. Class II Special Controls Guidance Document Data needed in a 510(k) submission Risks to health and recommended mitigation measures Biocompatibility testing Clinical testing Labeling

6. Types of Dental Device Designs To date FDA has cleared the following types of devices under this regulation: Tongue retaining devices Mandibular repositioning devices Palatal lifting devices

7. Cleared Indications Treating snoring Treating snoring and/or mild to moderate OSA Prescription use only

8. Tongue Retaining Device Mandibular Repositioning Device

9. Boil and Bite MandibularPalatal Lifting Repositioning Device

10. Trends in Device Design Mainly mandibular repositioning devices Early designs: –Custom impressions –Orthodontic hardware –Self-adjusting advancement mechanisms New Designs: –Boil and Bite devices Thermoplastic materials Pre-set advancements

11. Individual Impression Boil and Bite

12. Labeling Recommendations Contraindications Central sleep apnea Severe respiratory disorders Loose teeth or advanced periodontal disease Under 18 years of age Edentulous Warnings Use of device may cause: Tooth movement or changes in dental occlusion Gingival or dental soreness Pain or soreness of the TMJ Obstruction of oral breathing Excessive salivation

13. Clinical Testing for Snoring and/or OSA Submission Clearance Snoring – performance measurements that include rate of reduction of snoring based on clinical observation OSA – clinical data, that includes baseline and post-insertion polysomnograms measuring the apneic events, the apnea- hypopnea index, oxygen saturation, etc., are provided for a new design, new technology or new indication for use.

14. Differences from ENT Devices All dental devices for snoring and/or OSA are intraoral All dental devices are prescription devices, i.e., no intraoral dental devices for the treatment of snoring and/or OSA have been cleared as OTC devices Due to similarities in design, intraoral devices for both snoring and OSA pose similar risks based on correct selection and fitting of the appliance rather than whether the treatment is for snoring or OSA

15. Why cleared as prescription only devices? Intraoral devices present different risks than the ENT devices. –Varied in design and application –Correct selection and fitting is important in preventing injury Clinical care by a Dentist is critical in the diagnosis of: –Periodontal disease –Decayed, missing, and filled teeth –Protrusive range –TMJ status –Parafunctions – clenching and grinding

16. OTC Protocols Submitted The Dental Devices Branch has received clinical protocols from sponsors to support OTC use for the treatment of snoring and anticipate receiving protocols for OSA. Issues that have been addressed in the protocols include: the intervention of a dentist or other competent intermediary to assess the general health status, oral health status and/or the appropriateness of the individual device prior to the patient receiving the device Lay person self-assessment of snoring versus OSA Directions for use for self-fitting the oral appliance and self-assessment of the fit

17. Considerations for OTC Use OTC devices require adequate directions for use for the lay person. In discussing data for OTC use you may wish to consider the following: Can the lay person accurately self-diagnose their medical condition? Can the lay person accurately self-diagnose their oral health status? Can the lay person chose the correct oral appliance and fit it accurately such that the device is safe and effective and does not cause adverse events?