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

2. Snoring / OSA Devices Ear, Nose, Throat Devices Branch Nasal Dilators Nasal Dilators Cervical Pillows Cervical Pillows Mandibular Support Devices Mandibular Support Devices Anesthesiology and Respiratory Devices Branch CPAP CPAP General Surgery Devices Branch Lasers Lasers RF RF Dental Devices Branch Oral Appliances Oral Appliances Jaw Positioning Devices Jaw Positioning Devices

3. 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

4. Nasal Dilator (cont’d) Breathe With Eez TM Internal Nozovent ® External Breathe EZ TM Breathe Right Nasal Strip®

5. Nasal Dilators: OTC Snoring Indication K904290 Nozovent ® (WPM Int’l) – Clinical data provided to support snoring 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

6. 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

7. 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 use – Not for use under 5 yr

8. Nasal Dilators Cleared for Snoring OTC 510(k)DeviceCompanyClearance K904290Nozovent ® WPM International8/20/91 K953772Breathe Right ® Nasal Strip CNS, Inc.10/20/95 K955233Easy Breathing TM Corbet Lair, Inc.12/21/95 K962400AIR·MAX™American White Cross 9/9/96 K962698ClearPassage TM PowerStrip TM Acutek9/9/96 K874089Breathe With Eez TM Breathe With Eez, Inc. 5/7/98* (add to file) K982929MaxAir™HNL Technologies9/9/98

9. Cervical Pillows

10. No classification regulation for cervical pillows for snoring/OSA indications Fall within definition of medical device per §201(h) of FD&C Act

11. 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

12. 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 symptoms: 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”

13. 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. 1999;2:7-10. Kushida CA et al., Sleep Breath. 2001;5:71-8.

14. K990871PillowPositive II™ (cont’d) Cleared 6/10/99 for snoring and mild OSA Prescription use only Warnings/Contraindications

15. Cervical Pillows for Mild OSA OTC K023010 Popitz Pillow (Aeolus Int’l Corp.) – “sniff” position – Snoring/ mild OSA OTC indication cleared 10/01/02 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

16. Mandibular Support Devices Support mandible in the closed position – Similar to CPAP accessory chinstraps

17. 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 1991;71:2267-73

18. 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