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					Snoring and Obstructive Sleep Apnea (OSA)
  Devices for Over-the-counter (OTC) Use
     Ear, Nose, and Throat Devices Branch
                 October 6, 2004
            Snoring / OSA Devices

  Dental Devices Branch
                             Ear, Nose, Throat Devices Branch
    •Oral Appliances
 •Jaw Positioning Devices           • Nasal Dilators
                                   •Cervical Pillows
                              • Mandibular Support Devices

   Anesthesiology and
Respiratory Devices Branch
                             General Surgery Devices Branch
                Nasal Dilator
               21CFR 874.3900
• A nasal dilator is a device intended to provide
  temporary relief from transient causes of
  breathing difficulties resulting from structural
  abnormalities and/or transient causes of nasal
  congestion associated with reduced nasal
  airflow. The device decreases airway resistance
  and increases nasal airflow.
• Class I: ENT Devices Panel Meeting, Oct. 1990
• Cleared for OTC indications
              Nasal Dilator (cont’d)

    External                           Internal
                             Breathe With EezTM      Breathe EZTM
Breathe Right Nasal Strip®

Nasal Dilators: OTC Snoring Indication

• K904290 Nozovent® (WPM Int’l)
   – Clinical data provided to support
     • Petruson B. Arch Otolaryngol Head Neck
       Surg 1990;116:462-4.
     • Petruson B. Rhinology 1988;26:289-92.

  – Cleared 8/20/91 for snoring OTC
FDA Policy: Nasal Dilators for Snoring OTC
• Assuming same indications for use/
  technological characteristics no clinical
  data required
• Following FDAMAClass I (exempt) status
  effective 4/7/99
• New technological characteristics/new
  intended use would still require 510(k) and
  clinical data
• No OSA indications for use cleared to date
FDA Policy: Nasal Dilators for Snoring OTC

• Labeling Precautions/Warnings
   – Seek medical attention for abnormal
     breathing patterns during sleep, daytime
     sleepiness, difficulty breathing, etc.
   – Cease use if skin/mucosal irritation
   – Do not exceed recommended duration of
   – Not for use under 5 yr
 Nasal Dilators Cleared for Snoring OTC

510(k)    Device                 Company             Clearance
K904290   Nozovent®              WPM International   8/20/91

K953772   Breathe Right® Nasal   CNS, Inc.           10/20/95
K955233   Easy BreathingTM       Corbet Lair, Inc.   12/21/95

K962400   AIR·MAX™               American White      9/9/96
K962698   ClearPassageTM         Acutek              9/9/96
K874089   Breathe With EezTM     Breathe With Eez,   5/7/98*
                                 Inc.                (add to file)
K982929   MaxAir™                HNL Technologies    9/9/98
Cervical Pillows
              Cervical Pillows

• No classification regulation for cervical
  pillows for snoring/OSA indications
• Fall within definition of medical device per
  §201(h) of FD&C Act
   FDA Policy: “Snoring” Pillows
• Regulatory enforcement discretion applied
  for snoring indication only
   – No 510(k) Premarket Notification required
   – No enforcement of 21 CFR 807
     (Registration and Listing Requirements)
   – Still subject to adulteration and
     misbranding provisions of FD&C Act
   – Policy subject to change
 FDA Policy: “Snoring” Pillows (cont’d)
• Labeling Conditions
   – No other medical claims (e.g., OSA)
   – Warnings:
    “The user of this pillow should consult with their physician for
    evaluation of obstructive sleep apnea or other respiratory
    disorders if your snoring is accompanied by any of the following
      • Frequent excessive daytime sleepiness
      • Periods of not breathing, as observed by bed partners
      • Awakening short of breath, choking or gagging
  – Contraindications:
     • A history of heart disease
     • Being substantially overweight

     “Note: Not for use by infants or children
            Do not use if pain or discomfort results”
Cervical Pillows for OSA Indication

• K990871 PillowPositive II Cervical Pillow
           (Life Sleep Systems, Inc.)
  – Prior marketing for snoring indication
    (PillowPositive Cervical Pillow)
  – Submitted clinical data supporting mild
    OSA indication:
     • Kushida CA et al., Sleep Res Online.
     • Kushida CA et al., Sleep Breath. 2001;5:71-8.
K990871PillowPositive II™ (cont’d)

• Cleared 6/10/99 for snoring and mild OSA
• Prescription use only
• Warnings/Contraindications
Cervical Pillows for Mild OSA OTC
• K023010 Popitz Pillow (Aeolus Int’l Corp.)
   – “sniff” position
   – Snoring/mild OSA OTC indication cleared
     • Clinical data supporting effectiveness in mild OSA
     • Primary snoring vs. mild OSA
     • Long history of safe use for snoring pillows OTC
     • Adequate directions for use
• K040161 Sona Pillow (Sleep Devices, Inc.)
   – Cleared 4/30/04 for snoring/mild OSA OTC
   Mandibular Support Devices

• Support mandible
  in the closed
   – Similar to CPAP
 Mandibular Support Devices (cont’d)

• No classification regulation
• No 510(k)s to date
• Clinical studies
  – Meurice et al. Am J Respir Crit Care
    Med 1996;153:255-9
  – Hollowell et al. J Appl Physiol
           Adverse Event Reports
            (MAUDE Database)
• Nasal Dilator
   – 2 reports of skin irritation
   – 1 report eye irritation
   – 1 internal nasal dilator displaced into posterior
     nasal cavity
• Cervical Pillows
   – No adverse events to date
• Mandibular Support Device
   – One transient case of airway obstruction with
     an illegally marketed device

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