Snoring and Obstructive Sleep Apnea (OSA) Snoring and Obstructive Sleep Apnea (OSA) Devices for Over-the-counter (OTC) Use Devices for Over-the-counter (OTC) Use Ear, Nose, and Throat Devices Branch Ear, Nose, and Throat Devices Branch October 6, 2004
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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.
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Snoring and Obstructive Sleep Apnea Snoring and Obstructive Sleep Apnea (OSA) Devices for Over-the-counter (OSA) Devices for Over-the-counter
(OTC) Use(OTC) Use
Ear, Nose, and Throat Devices BranchEar, Nose, and Throat Devices Branch October 6, 2004
• 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)Nasal Dilator (cont’d)
Breathe With Breathe With EezEezTMTM
InternalInternal
NozoventNozovent®®
ExternalExternalBreathe EZBreathe EZTMTM
Breathe Right Nasal Breathe Right Nasal Strip®Strip®
K955233 Easy BreathingTM Corbet Lair, Inc. 12/21/95
K962400 AIR·MAX™ American White Cross
9/9/96
K962698 ClearPassageTM
PowerStripTM
Acutek 9/9/96
K874089 Breathe With EezTM
Breathe With Eez, Inc.
5/7/98*(add to file)
K982929 MaxAir™ HNL Technologies 9/9/98
Cervical PillowsCervical Pillows
Cervical PillowsCervical 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” FDA Policy: “Snoring” PillowsPillows
• 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 FDA Policy: “Snoring” Pillows (cont’d)(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”
Cervical Pillows for OSA Cervical Pillows for OSA IndicationIndication
• 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-