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 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. Mandibular Repositioning Device
Tongue Retaining Device

9. Boil and Bite Mandibular Palatal 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?