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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 – PowerPoint PPT presentation

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Title: Snoring and Obstructive Sleep Apnea (OSA) Devices


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
  • 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?
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