Snoring and Obstructive Sleep Apnea (OSA) Devices

Dental Devices BranchDivision of Anesthesiology, General

Hospital, Infection Control and Dental Devices

October 6, 2004

Kevin Mulry, D.D.S., M.P.H.

Scope of Dental Devices for Panel Discussion

Includes:• Intraoral devices

– fitted over teeth– removable

Does not include:• Implantable devices• Surgical devices • CPAP• Diagnostic Devices

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.

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.

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

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

Cleared Indications

• Treating snoring

• Treating snoring and/or mild to moderate OSA

• Prescription use only

• Tongue Retaining Device

• Mandibular Repositioning Device

Boil and Bite Mandibular Palatal Lifting Repositioning Device

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

Individual Impression Boil and Bite

Labeling Recommendations

Contraindications• Central sleep apnea• Severe respiratory disorders• Loose teeth or advanced periodontal disease• Under 18 years of age• Edentulous

WarningsUse 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

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.

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

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

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

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?