CLA-2-90:OT:RR:NC:N3:135
Derek Madden
Neuromod Devices Limited
Unit J, Digital Court, The Digital Hub, Rainsford Street
Dublin D08 R2YP
Ireland
RE: The tariff classification of a tinnitus treatment device from Ireland
Dear Mr. Madden:
In your letter dated December 16, 2025, you requested a tariff classification ruling.
The “Lenire® Tinnitus Treatment Device” (“Lenire device”), model CR-201, is a non-invasive bimodal
neuromodulation device specifically designed for the adaptation and relief of tinnitus. It combines auditory
and trigeminal nerve stimulation to alleviate symptoms associated with tinnitus. The Lenire device consists of
several component parts: a Controller (CR-201), a Tongue Tip (TP-101), a carry case (CE-401), a power
supply (XP Power ACM06US05W-XZ1663A), and headphones (Austrian Audio Hi-X25BT). The Controller
is a lightweight handheld device that coordinates the system’s bimodal neuromodulation by managing the
timing, intensity, and synchronization of auditory stimulation (via Bluetooth headphones) with transmucosal
tongue stimulation (via the Tongue Tip). The Tongue Tip is an intra-oral stimulation device designed to
deliver mild electrical pulses to the tongue, activating neural pathways to the brain. It consists of a slim,
flexible probe with integrated electrodes and a microUSB connector for attachment to the Controller. The
carry case is designed to hold the Tongue Tip and its cable within the body of the case. The power supply
provides the necessary charging capability for the Lenire® Controller and, where applicable, the wireless
headphones. The headphones provide customized sounds to stimulate the auditory nerve. The Lenire device
is prescription-only and must be fitted and configured by a suitably qualified audiologist or physician, who is
experienced in the evaluation and management of tinnitus. Users intend to operate the device at home
following clinical setup, with recommended daily sessions lasting 30 to 60 minutes.
Your letter proposes classifying the Lenire device under subheading 9018.90.8000, Harmonized Tariff
Schedule of the United States (HTSUS), which covers “other” instruments and apparatus used in medical,
surgical, dental, or veterinary sciences, and parts and accessories thereof. We disagree. Before classifying
merchandise under a residual or “basket” provision like subheading 9018.90.80, HTSUS, we must first
determine if it falls within the scope of a more specific subheading. In this instance, because the Lenire
device is electrically powered, it constitutes an “electro-medical instrument and appliance” under subheading
9018.90.75, HTSUS. Therefore, it is not classifiable under the residual provision of subheading 9018.90.80,
HTSUS.
The applicable subheading for the Lenire device will be 9018.90.7560, HTSUS, which provides for
“Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic
apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Other
instruments and appliances and parts and accessories thereof: Other: Electro-medical instruments and
appliances and parts and accessories thereof: Other: Other: Other therapeutic appliances and instruments:
Other.” The general rate of duty will be free.
In your submission you requested consideration of a secondary classification under 9817.00.96, Harmonized
Tariff Schedule of the United Sates (HTSUS), which applies to articles and parts and accessories of articles
specifically designed or adapted for the use or benefit of the permanently or chronically physically or
mentally handicapped.
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.” 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.
Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals
for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 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” and adopted the five factors used by U.S. Customs and Border Protection
(CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present 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) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
Your website (https://www.lenire.com/understanding-tinnitus/) defines tinnitus as the perception of sound in
the ears without an external source, often described as ringing, buzzing, hissing, or thumping. The U.S.
National Institutes of Health (https://www.nidcd.nih.gov/health/tinnitus) further clarifies that tinnitus lasting
three months or longer is considered chronic, and that it is “only rarely associated with a serious medical
problem and is usually not severe enough to interfere with daily life.” Your website also identifies the
Tinnitus Handicap Inventory (THI) as a common measurement scale, noting that a higher score (on a 1-100
scale) indicates a greater impact on quality of life. Our research indicates that the average THI score for
individuals with chronic tinnitus typically falls within the moderate handicap range, though specific averages
vary across studies. Given the above, and the absence of evidence demonstrating that the Lenire device is
primarily designed for physically handicapped persons, it is our opinion that the device will not qualify for
Nairobi Protocol treatment under subheading 9817.00.96, HTSUS.
The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience
and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided
at https://hts.usitc.gov/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division