# Presentation: 452022

## Ear, Nose, and Throat Devices Branch 

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

**October 6, 2004**

**Notes:**
Good morning and welcome to our distinguished panel members, FDA colleagues and guests.  This certainly is a rare opportunity for FDA to have access to such a wealth of clinical experience from both the dental and ENT Advisory Panels.  We very much appreciate your willingness to attend and prepare for this meeting and to share your knowledge with us as we consider important regulatory questions related to over-the-counter use of medical devices for the treatment of snoring and obstructive sleep apnea.  I would like to open this morning’s session by giving you a brief history of the subset of Ear, Nose and Throat devices which have been proposed and in some cases cleared, for over the counter treatment of snoring and obstructive sleep apnea.  

## Slide 2

**Notes:**
As we’re all aware there have been a large variety of devices that have been cleared over the years for the treatment of snoring and/or OSA.  For those of you who are less familiar with FDA, what I’ve illustrated in this slide is that we don’t have a specific division or branch that deals with snoring or OSA devices.  And in fact there are at least four branches that regulate these sorts of devices.  The dental branch has regulated oral appliances, jaw positioning devices,and an assortment of other devices such as palatal implants and the Repose tongue base suture system and Dr. Mulry will be discussing some of these shortly. My Branch, the Ear, Nose and Throat Devices Branch has regulated Nasal dilators, cervical pillows for snoring/OSA, and mandibular support devices.  The anesthesiology and respiratory diseases branch has regulated the wide variety of CPAP type-devices, which of course are considered as the mainstay of OSA treatment and finally the General Surgery Devices Branch regulates some of the devices with more generic surgical application such as lasers and devices using RF. There is frequent formal and informal consultation between branches on an as-needed basis to address specific clinical or technological questions or issues. 	And I’d like to emphasize that, for the purposes of today’s discussion, we will only be discussing those devices that have been proposed for OTC use which would obviously not include the surgical or CPAP devices. So with that background, I’d like to now move to a discussion of the specific devices within my 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**

**Notes:**
And I’d like to begin with a discussion of the nasal dilator which is described in the Code of Federal Regulations as....

## Nasal Dilator (cont’d)

**Breathe With Eez****TM**

***Internal***

**Nozovent****®**

***External***

**Breathe EZ****TM**

**Breathe Right Nasal Strip®**

**Notes:**
And the regulations go on to describe external vs. internal versions of the nasal dilators and here are a few examples that have been cleared.   Most of us are quite familiar with the external nasal dilator such as the Breathe Right Nasal Strip.  It has skin adhesive on one side coupled to a spring like material strip and is place over the skin of the nasal dorsum to pull open the lateral walls in the nasal valve region.  There are a variety of designs for the internal dilator which are actually inserted into the nostrils to expand and support the distal nasal airway. Note, in particular the Nozovent device here at the bottom.  It consists of a springy center strut which has phalanges on either end that are inserted into the nostrils and splay the nasal alae laterally to expand the airway.  In general, the cleared indications for use for the early nasal dilators were things like enhanced nasal breathing, increased nasal airway, or decreased nasal resistance.

## 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**

**Notes:**
Nozovent was the first company to submit a 510(k) to the Agency for the indication of snoring for their nasal dilator. This was considering a new indication for use and the sponsor did provide clinical data to support the safety and effectiveness for snoring.  While I can’t provide all specific information on the data included within that submission due to confidentiality issues, it did include references to published clinical studies of the device supporting the safety and effectiveness in snoring individuals.  Based on the information provided the 510(k) was cleared in August of 1991 and opened the door for other nasal dilators to seek this indication.

## 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 **

**Notes:**
FDAs regulatory policy following the Nozovent clearance was that nasal dilators with the same intended use and technological characteristics to a predicate device like Nozovent would not need clinical data and could use bench data such as material and design specifications and testing, etc. to support substantial equivalence and clearance. However, new technology or indications for use would require clinical data. So for example when Breathe Right nasal strip came in with a 510(k) for snoring, they were required to provide clinical data to support a snoring claim because the design of their device and technological characteristics of their external device were different from Nozovent. One of the things that happened in the late nineties was the passage of Food and Drug Modernization Act (FDAMA).  And as a result of this legislation nasal dilators and the vast majority of all Class I medical devices became exempt from premarket notification or 510(k) requirements. So we have pretty much stopped seeing 510(k)s for these devices unless there is a new technological characteristic or intended use for the device and in this case the limits of the exemption would be exceeded and the company would be required to submit a 510(k).  Of note, FDA has cleared no nasal dilator device for the treatment of OSA 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 use**
**Not for use under 5 yr**

**Notes:**
And, in addition, the Agency has reviewed the labeling of these devices to ensure that the following precautions and warnings have been included.  The precise wording has varied somewhat, but consumers have been instructed to seek medical attention for signs/symptoms suggestive of OSA/sleep disordered breathing; to cease use if there is skin or mucosal irritation resulting from use of the device; precautions not to exceed the recommended duration of use or use in children younger than 5 yr.

## Nasal Dilators Cleared for Snoring OTC

| 510(k) | Device | Company | Clearance |
| --- | --- | --- | --- |
| K904290 | Nozovent® | WPM International | 8/20/91 |
| K953772 | Breathe Right® Nasal Strip | CNS, Inc. | 10/20/95 |
| K955233 | Easy BreathingTM | Corbet Lair, Inc. | 12/21/95 |
| K962400 | AIR·MAXTM | 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 | MaxAirTM | HNL Technologies | 9/9/98 |

**Notes:**
And here is a list of nasal dilators cleared for snoring that I was able to compile from a quick search of our computerized database.  This list is by no means comprehensive since, as I discussed, 510(k)s are no longer required for these devices subject to the limits of the exemption.

## Cervical Pillows

**Notes:**
Shifting gears a bit, I like to discuss cervical pillows which have also been regulated by our Branch. 

## 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**

**Notes:**
We have no classification regulation for cervical pillows for snoring or OSA indications. 

## 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**

**Notes:**
Noting the sudden surge in 510(k)s for snoring pillows, the agency had to consider how best to regulate them and developed the following policy. But given the potentially large number of these sorts of devices, the minimal risks associated with using a pillow, and the finite resources of the agency, FDA decided in this situation to apply regulatory enforcement discretion for the specific single indication of snoring –not OSA. Using this discretion, the policy has been that no 510(k)s are required, there has been no enforcement of the registration and listing requirements, but the devices are still subject to the adulteration and misbranding provisions of the Act. And FDA has always reserved the option to change this policy if deemed necessary. So manufacturers submitting a 510(k) for a pillow with just the snoring indication have been issued a letter describing this policy.
Regulatory enforcment-case by case basis
Policy changes in FR notice

## 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”**

**Notes:**
Now the letters have made the regulatory discretion contingent upon the sponsor agreeing to include the following labeling for consumers.

## 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.*

**Notes:**
Life Sleep Systems was the first company to seek an indication for mild sleep apnea. This obviously was a new indication for use and triggered the requirement for them to submit a 510(k) and clinical data to support this indication.  Although I can’t present the content of the 510(k), the type of clinical data used to support the clearance has been published in several studies done at the Stanford University sleep center and demonstrated a reduction in RDI with use of the pillow one of which was included in the Panel briefing package.

## K990871PillowPositive IITM (cont’d)

**Cleared 6/10/99 for snoring and *****mild *****OSA**
**Prescription use only**
**Warnings/Contraindications**

**Notes:**
Based on this and other information with the 510(K) and the recognition that there may be some bluriness of the line between simple snoring and mild OSA, the PillowPositive II was cleared in June of 1999 for snoring and mild OSA.  Of note, this first clearance was for prescription use only.
As I stated earlier we have no classification regulation for snoring pillows so for the OSA indication, a new product code was created for cervical pillows for the treatment of mild OSA which allows us to easily identify these devices within our computerized databases
Precautions/warnings within the labeling were essentially the same as for nasal dilators: consult physician for OSA symptoms; discontinue use for pain/discomfort; not for use in children.  

## 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**

**Notes:**
In Sept. 2002, we received another 510(k) for the indication of snoring and OSA. Again, similar to the PillowPositive II in terms of positioning the head in the sniff position to open the airway, and on the basis of information submitted were able to establish substantial equivalence. So this one was cleared in Sept. of 2002 for again snoring and mild OSA and for this 

## Mandibular Support Devices

**Support mandible in the closed position**
**Similar to CPAP accessory chinstraps**

**Notes:**
The final group of devices I’d like to very briefly mention are the mandibular support devices which essentially hold the mandible in the closed position during sleep much like the CPAP chinstrap devices shown here.

## 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*

**Notes:**
Like snoring/OSA pillows, we have no classification regulation for these devices and have actually received no 510(k)s for these devices to date.  I mention them because we have receive numerous inquiries from industry about the regulatory requirements for clearance of such devices for both snoring and OSA.  And, in general, they have cited literature such as the two references cited here which essentially show that mouth opening appears to be associated with narrowing and collapsibility of the upper airway in normal and OSA subjects. So we may be seeing these devices coming into FDA in the near future.

## 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**

**Notes:**
In reviewing the FDAs computerized adverse events database which contains both voluntary and mandatory reports to the Agency, the adverse events reports related to these devices have generally been few and minor in nature.  There were two reports of skin irritation associated with external nasal strips, 1 report of eye irritation although it was clear from the report how suspect the device was in this case, and there was 1 report of an internal nasal dilator being displaced into the posterior nasal cavity.

I was unable to find any adverse event reports for cervical pillows. Of some concern was a report of transient airway obstruction in a consumer using an illegally (?) marketed mandibular support device for ?snoring/osa.  They awoke gasping for air unable to breathe apparent as a result of the oral airway being closed by the device. Fortunately, there were no sequellae from this event.  But I would add parenthetically that there is likely underreporting of many of the less serious adverse events with these devices. Dr. Mair was a coauthor on a clinical study looking at the safety and effectiveness of some of these devices and found little or no evidence of effectiveness for snoring and a fair number (?) of these types of minor events such as skin irritation.