H351118

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%20p

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