Articles for the handicapped; Subheading 9817.00.96; Oral Appliances for Obstructive Sleep Apnea

H351118 January 23, 2026 OT:RR:CTF:VS H351118 AMW CATEGORY: Classification Mr. Matthew Malabey Dynaflex 8050 Hawk Ridge Trail Lake St. Louis, Missouri 63367 RE: Articles for the handicapped; Subheading 9817.00.96; Oral Appliances for Obstructive Sleep Apnea Dear Mr. Malabey: This is in response to your request for a binding ruling regarding the applicability for duty-free treatment under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), to five models of devices used for the treatment of obstructive sleep apnea and snoring (the “Oral Appliances”). The National Commodity Specialist Division forwarded your request to this office along with the corresponding supporting documentation for our review and determination. FACTS: The following facts are based on your request, dated June 24, 2025, as well as follow-up information provided on November 11, 2025. The Oral Appliances are custom-made mandibular advancement devices (“MADs”) used for the treatment of mild-to-moderate obstructive sleep apnea (“OSA”) and non-OSA-related snoring. OSA occurs when the muscles and soft tissue at the back of the throat relax and collapse while a person is sleeping. As a result, the tongue or soft tissue can block that person’s airway and disrupt breathing. The Oral Appliances treat OSA by pushing the user’s lower jaw (i.e., mandible) forward, which also pulls the tongue forward and creates space for airflow in the back of the throat. This function also serves to treat snoring. The Oral Appliances are molded to fit over a user’s teeth, and are comprised of two parts: one for the top teeth and another for the bottom. The five models of DynaFlex-brand oral appliances subject to your request are identified as follows: • Dorsal: consists of lower and upper devices made of acrylic or acrylic and chrome. The acrylic fins on the mandibular (lower) device engage with inclines on the buccal of the maxillary (upper) device to dictate a specific mandibular position. The Dorsal features adjustable screws in the upper device to enable further advancement. • Adjustable Herbst: a two-piece device held together with two inseparable hinged mechanisms on the facial side of the upper and lower appliances. The hinged mechanisms contain advancement screws that enable for titration and advancement of the mandible. • Respire Blue +: a two-piece device featuring a dual-block design with interlocking wings. The device features a four-wing design (two adjustable and two fixed), which enables additional support and balance during lateral movements. The wings are shorter, narrower, and thinner, which produces a smaller overall size intended for improved comfort. • Respire AT (Advanced Titration): a two-piece device connected by a hinge with telescopic hardware and a simplified titration mechanism. The mechanism offers precise adjustments with measuring scales on arms that provide adjustment up to 7 mm. • Respire Micro AT: contains the same features as the Respire AT, above, but is designed for patients with smaller mouths. The Oral Appliances are available via prescription. The process for obtaining one of the Oral Appliances is as follows: after conducting a sleep study or otherwise diagnosing a patient, a medical doctor will consider a course of treatment for the patient. If the doctor determines the patient should be treated with a MAD, the patient is referred to a dentist to arrange a prescription. If the dentist prescribes one of the subject Oral Appliances, the dentist will take either a physical mold of the patient’s teeth (i.e., an impression) or make a digital scan of the patient’s arch and bite. After an impression or scan is made, the physical mold or electronic files are transferred to an overseas dental laboratory, which will manufacture an Oral Appliance to fit the patient. The Oral Appliances may be fabricated using traditional methods such as thermoforming, hand-packing acrylic, and lost-wax techniques, or through modern digital processes like CAD/CAM milling and 3d printing to produce an acrylic mold of the teeth. After the acrylic mold is completed, the metal components, such as the hinges and titration mechanisms described above, are added to produce the completed Oral Appliance. Following this, the Oral Appliances are exported to the United States. Upon arrival in the United States, each Oral Appliance will be inspected and packaged in accordance with U.S. Food and Drug Administration regulations, and eventually provided to the patient for their use. The case file indicates that the Oral Appliances are capable of use in treating OSA as well as non-OSA-related snoring. You have provided testimonials from several sleep medicine professionals explaining that they have prescribed the devices to treat mild-to-moderate OSA. Dynaflex’s website, furthermore, markets the devices for treatment of both OSA and snoring. In 2 relevant part, the website notes: “Do you have patients who snore, or have [OSA]….DynaFlex offers a number of high quality superior OAT devices for patients who snore or suffer from sleep apnea.”1 ISSUE: Whether the subject Oral Appliances are eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as “articles specially designed or adapted for the handicapped.” LAW AND ANALYSIS: The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty- free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles . . . Other.” Thus, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. As a preliminary matter, we determine OSA satisfies this definition. Obstructive sleep apnea is not an acute or transient condition, but rather a chronic condition requiring ongoing treatment.2 Complications of OSA may include difficulty breathing while sleeping, daytime fatigue, high blood pressure and heart problems, type-2 diabetes, metabolic syndrome, and liver problems.3 Indeed, CBP has previously recognized that merchandise used to treat OSA is eligible for secondary classification under subheading 9817.00.96, HTSUS. See, e.g., NY N314820, dated October 16, 2020 (involving a printed circuit board designed for use in a respiratory therapy machine used to treat OSA). We also determine, however, that snoring on 1 See DynaFlex “Dental Sleep Medecine Laboratory” page, available at https://www.dynaflex.com/dental-sleep- laboratory-devices/?srsltid=AfmBOop_XDWkG_iMAkJexzVQB4HaVKtM8KPyFKl7RU8R6VVrmUmyrJ2y (accessed January 13, 2026). 2 See “Obstructive sleep apnoea in adults: a chronic condition in need of a comprehensive chronic condition management approach,” available at https://pubmed.ncbi.nlm.nih.gov/23434125/#:~:text=Abstract,are%20properly%20acknowledged%20and%20addres sed. (accessed November 13, 2025). 3 See Mayo Clinic Overview of Sleep Apnea, available at https://www.mayoclinic.org/diseases-conditions/sleep- apnea/symptoms-causes/syc-20377631 (accessed November 13, 2025). 3 its own does not fall within the definition of a physical or mental handicap. Instead, snoring is “a common condition that can disrupt your sleep” but “[m]ild or occasional snoring usually isn’t a cause for concern….”4 Next, we determine the subject Oral Appliances are not “specially designed or adapted” for the treatment of OSA. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). The U.S. Court of Appeals for the Federal Circuit (“CAFC”) clarified that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others. This definition of ‘specially designed’ is consistent with factors that Customs uses in discerning for whose use and benefit a product is ‘specially designed’ … we adopt them in our analysis ….” Sigvaris, 899 F.3d at 1314- 15. U.S. Customs and Border Protection (“CBP”) examines the following five factors adopted by the CAFC in Sigvaris, 899 F.3d at 1314-15: (1) physical properties of the article itself (e.g., whether the article is easily distinguishable in design, form, and use from articles useful to non- handicapped persons); (2) presence of any characteristics that create a substantial probability of use by the chronically handicapped, so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) importation by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) sale in specialty stores that serve handicapped individuals; and (5) indication at the time of importation that the article is for the handicapped. See also Treasury Decision 92-77, 26 Cust. B. & Dec. 240 (1992). Furthermore, CBP has recognized that these factors are to be weighed against each other on a case-by-case basis when determining whether a particular product is “specially designed or adapted” for the use of handicapped persons. See, e.g., HQ H300660, dated February 27, 2019 (citing Implementation of the Nairobi Protocol, 26 Cust. Bull. & Dec. at 234-244). Here, the Sigvaris factors indicate the subject Oral Appliances are not specially designed for the use or benefit of persons with a disability such as OSA. To begin with, the Oral Appliances are not easily distinguishable in design, form, and use from articles useful to non- handicapped persons. An internet search for “anti-snoring” devices reveals multiple over-the- counter devices consisting of an upper and lower portion designed to advance the lower jaw that are specifically marketed and described as “anti-snoring” mouthpieces.5 With respect to the 4 See Cleveland Clinic, “What is Snoring,” available at, https://my.clevelandclinic.org/health/diseases/15580- snoring (accessed January 13, 2026). 5 See, e.g., Amazon listing for “ZQuite, Advance, Custom Anti-Snoring Mouthpiece,” available at https://www.amazon.com/dp/B0DMXMBRS8/ref=sspa_dk_detail_2?psc=1&pd_rd_i=B0DMXMBRS8&pd_rd_w= 4 second Sigvaris factor, the characteristics of the Oral Appliances further do not create a substantial probability of use by individuals with OSA as opposed to those who might use the device to mitigate non-OSA snoring such that the devices would be easily distinguishable. Indeed, as with the first factor, the Oral Appliances share the same general physical characteristics and mechanics (e.g., top and bottom retainers, adjustable advancement of the lower jaw) as devices sold to the general public for the treatment of snoring. Next, with respect to the fourth Sigvaris factor, although the instant Oral Appliances are not available in general retail, they are not specifically marketed for handicapped individuals. As noted above, the DynaFlex website itself advertises the Oral Appliances for treatment of both OSA and non-OSA snoring. As previously noted, CBP weighs the five factors listed above on a case-by-case basis. On balance, we find that the Oral Appliances are not eligible for duty-free treatment under subheading 9817.00.96, HTSUS. HOLDING: The five Oral Appliances described in the instant request, Dorsal, Herbst, Respire Blue+, Respire AT, and Respire Micro AT, are not eligible for subheading 9817.00.96, HTSUS, treatment, which provides for “articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons . . . other.” Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the assumption that all of the information furnished in connection with the ruling request and incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and complete in every material respect. The application of a ruling letter by [CBP] field office to the transaction to which it is purported to relate is subject to the verification of the facts incorporated in the ruling letter, a comparison of the transaction described therein to the actual transaction, and the satisfaction of any conditions on which the ruling was based. A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the CBP officer handling the transaction. Sincerely, Monika R. Brenner, Chief Valuation and Special Programs Branch 6S0Dz&content-id=amzn1.sym.e1bd46f6-106d-4001-8a1f-c5226d6c67ac&pf_rd_p=e1bd46f6-106d-4001-8a1f- c5226d6c67ac&pf_rd_r=2KAMM4KGN1Z4PV4D0XWM&pd_rd_wg=5QttZ&pd_rd_r=6d59d48b-3b27-4125- 8663-5689b9fcba54&sp_csd=d2lkZ2V0TmFtZT1zcF9kZXRhaWxfdGhlbWF0aWM (accessed January 13, 2026). 5