Snoring and Obstructive Sleep Apnea (OSA) Devices

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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.

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Scope of Dental Devices for Panel Discussion

• Includes
• Intraoral devices
• fitted over teeth
• removable
• Does not include
• Implantable devices
• Surgical devices
• CPAP
• Diagnostic Devices

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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.

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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.

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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

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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

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Cleared Indications

• Treating snoring
• Treating snoring and/or mild to moderate OSA
• Prescription use only

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• Mandibular Repositioning Device

• Tongue Retaining Device

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• Boil and Bite Mandibular Palatal Lifting
  Repositioning Device

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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

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Individual Impression Boil and Bite
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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

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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.

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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

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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

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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

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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?