OT:RR:CTF:EMAIN H313006 JRG
Mr. David Prata
Geodis USA Freight Forwarding
1 CVS Drive
Woonsocket, RI 02895
Re: Revocation of New York Ruling Letter (NY) N283085, NY N166443, NY N025447, and NY D80822
Dear Mr. Prata:
This is to inform you that U.S. Customs and Border Protection ("CBP") has reconsidered New York Ruling Letter (NY) N283085, dated February 28, 2017, regarding the classification of a "Hearing Amplifier Kit." Additionally, we have also reconsidered NY N166443[1], N025447[2], and D80822[3], all of which deal with the classification of certain hearing amplification devices.
Pursuant to Section 625(c)(1), Tariff Act of 1930 (19 U.S.C. 1625(c)(1)), as amended by Section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act, Pub. L. No. 103-182, 107 Stat. 2057, 2186 (1993), notice of the proposed action was published on August 14, 2024, in Volume 58, Number 32, of the Customs Bulletin. No comments were received in response to this notice.
FACTS:
In NY N283085, your product is briefly described as follows:
...a retail-ready kit, comprised of a sound amplifier, three plastic earplugs in different sizes, a spare battery, and a plastic storage case. This product is intended to be worn as an in-ear sound amplification device.
In N166443, the Personal Sound Amplifier, is described as an earpiece with an on/off switch, volume button to switch between three sound settings, a microphone to pick up sounds in the user's immediate surroundings, a tube to carry the audio from the earpiece directly into the ear, a tube connector which attaches the tube to the earpiece, and the dome, which fits securely in the ear, similar to an earbud. We note that the Personal Sound Amplifier does not require a prescription or a hearing test for purchase and is not sold or intended for use as a hearing aid for FDA (Food & Drug Administration) purposes. The PockeTalkers classified in N025447 include a variety of models. In essence, they are described as personal sound amplifiers that consist of an amplifier, batteries, microphone, ear bud, and folding headphones. Finally, the Assistive Listening Device in NY D80822 is described as a device that consists of a small microphone and amplifier with a volume control that rests in the ear. The unit is designed to enhance listening and hearing in conversation or in group activities. It does not require a special prescription from an audiologist or hearing aid specialist. It is sold at retail in pharmacies or via direct advertising.
The above referenced rulings describe the subject merchandise as "amplifying" sound to the extent that all of the subject articles are indeed designed to increase the volume of sounds for the user. However, we understand that in their condition as imported, the subject products are in the form of a headphone or earphone that feature, in addition to an "amplifier", feature at least a microphone.
ISSUE:
Whether the hearing amplification devices are classified as other headphones and earphones of heading 8518, HTSUS, or hearing aids of heading 9021, HTSUS.
LAW AND ANALYSIS:
Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context which requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all purposes.
General Rule of Interpretation 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.
The Harmonized Commodity Description and Coding System Explanatory Notes ("ENs") constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The HTSUS provisions under consideration are:
8518 Microphones and stands therefor; loudspeakers, whether or not mounted in their enclosures; headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers; audio-frequency electric amplifiers; electric sound amplifier sets; parts thereof:
8518.30 Headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers:
8518.30.20 Other
* * *
9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:
9021.40 Hearing aids, excluding parts and accessories thereof
Note 1(m) to Section XVI states that the Section does not cover articles of Chapter 90. As such, we must first determine whether the hearing amplifiers at issue are goods of Chapter 90. Additionally, the EN to Chapter 85 states that the heading excludes hearing aids of heading 9021, HTSUS.
Heading 9021, HTSUS, provides for, inter alia, hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability. The term "hearing aids" is not defined in the legal texts of the HTSUS. A tariff term that is not defined in the HTSUS is construed in accordance with its common and commercial meaning. Nippon Kogasku (USA), Inc. v. United States, 69 CCPA 89, 673 F.2d 380 (1982). Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities and other reliable sources. C.J. Tower & Sons v. United States, 69 CCPA 128, 673 F.2d 1268 (1982). Further, the EN to heading 9021, HTSUS, provides guidance. Part IV of the EN, titled "Hearing Aids" gives a brief technical description of the products, i.e., that they are generally electrical appliances with a circuit containing one or more microphones (with or without amplifier), a receiver and a battery. The receiver may be worn internally or behind the ear, or it may be designed to be held in the hand against the ear. Additionally, the EN states that hearing aids of heading 9021, HTSUS, are restricted to appliances for overcoming deafness (emphasis added). It goes on to explain that certain devices, such as headphones, amplifiers and the like used in conference rooms or by telephonists to improve the audibility of speech are excluded from heading 9021, HTSUS. This is not an exhaustive list of excluded devices.
The Online Webster Dictionary defines a "defect" as an imperfection or abnormality that impairs quality, function, or utility.[4] It defines a "disability" as a physical, mental, cognitive, or developmental condition that impairs, interferes with, or limits a person's ability to engage in certain tasks or actions or participate in typical daily activities and interactions.[5] Finally, it defines "deaf" as "lacking or deficient in the sense of hearing."[6] "'Deaf' people mostly have profound hearing loss, which implies very little or no hearing."[7] "'Deaf' usually refers to a hearing loss so severe that there is very little or no functional hearing."[8] The Cambridge Dictionary defines "deafness" as "the quality of being unable to hear, either completely or partly."[9]
The degree of hearing loss can range from mild to profound:[10]
1) Mild Hearing Loss
A person with a mild hearing loss may hear some speech sounds but soft sounds are hard to hear.
2) Moderate Hearing Loss
A person with a moderate hearing loss may hear almost no speech when another person is talking at a normal level.
3) Severe Hearing Loss
A person with severe hearing loss will hear no speech when a person is talking at a normal level and only some loud sounds.
4) Profound Hearing Loss
A person with a profound hearing loss will not hear any speech and only very loud sounds.
An online article explains what a hearing aid is and how hearing aids help with hearing loss.[11] It states:
Hearing aids are small electronic devices that can be highly customized to address different types of hearing loss. All digital hearing aids contain at least one microphone to pick up sound, a computer chip that amplifies and processes sound, a speaker that sends the signal to your ear and a battery for power. More sophisticated models provide additional features, such as direct connection to a smartphone or neural networks.
* * *
A hearing aid amplifies the sounds going into the ear. They are most often prescribed for people who have a type of hearing loss known as "sensorineural," meaning that some of the tiny hair cells of the inner ear are damaged. The surviving healthy hair cells pick up the sound delivered by the hearing aid and send them as neural signals to the brain via the auditory nerve.
For people with mild-to-moderate hearing loss, standard hearing aids work best. "Power" models are often used for people who have severe-to-profound hearing loss as the batteries require more power.
Based on online research, a hearing aid is a doctor-prescribed device based on the patient's hearing test result and usually custom-programmed by a hearing care professional to suit the patient's specific hearing loss and listening needs.
Hearing aids are a kind of assistive listening devices,[12] but not all assistive listening devices are hearing aids. "Hearing aids are the best all-around solution for people with hearing loss, but other assistive listening devices (ALDs) can help you navigate specific communication demands."[13] "Some of these devices [ALDs] are made to work specifically with certain hearing aids while others are stand-alone and can be helpful-even if you don't yet wear hearing aids ... Assistive listening devices include amplified telephones, hearing aid compatible phones and smartphones, television compatible devices, FM systems for public settings, and alerting devices.[14]" Accordingly, heading 9021, HTSUS, as it relates to the provision for "hearing aids", does not cover all assistive listening devices.
Based on the Hearing Aid Museum website, the personal sound amplifier products (PSAPs) are also considered assistive listening devices.[15] However, personal sound amplifier products and hearing aids are two different product categories. We understand the three principal differences between PSAPs and hearing aids as follows:[16]
Difference #1: Class of product
PSAPs are basic sound amplifiers for those who do not have hearing loss. The FDA does not regulate them and says they are designed to "increase environmental sounds for non-hearing impaired consumers." On the other hand, hearing aids are FDA-regulated medical devices that are intended to compensate for hearing loss and be customized to your needs.
Difference #2: Amplification style
Most PSAPs amplify all sounds within a given radius, even those you don't want to hear. This can actually damage (instead of help) your hearing. Modern hearing aids, on the other hand, use broadband technology and filters to selectively amplify the sounds you need to hear, while reducing background noise and feedback. This can make a huge difference - for example, in a noisy restaurant where amplifying all sounds equally (a companion's speech plus background noise) would make it virtually impossible to hear a conversation.
Difference #3: Fit and features
Most PSAPs only consist of a microphone, amplifier and receiver (mini-loudspeaker). In addition, they are only available in standard settings and are typically one size fits all. Hearing aids, however, are custom-programmed by a hearing care professional to suit your specific hearing loss and listening needs. Hearing aids are available with advanced features such as directional microphones, tinnitus control and streaming capabilities. They can also be custom-molded for a secure and ultra-comfortable fit.
This is supported by additional internet research that differentiates hearing aids from other sound amplification devices.[17] In sum, our research has indicated that unlike sound amplification devices, such as PSAPs, hearing aids are sophisticated, highly customized devices tailored to a user's specific hearing deficits. While PSAPs amplify all sounds, hearing aids are programmed to amplify only the sounds a user cannot hear well. Because PSAPs amplify all sounds, they can potentially cause more harm than good to the users and are not recommended as a replacement for hearing aids.
While these personal sound amplifiers may help people hear things that are at low volume or at a distance, the Food and Drug Administration (FDA) wants to ensure that consumers don't mistake them-or use them as substitutes-for approved hearing aids.
Hearing aids and PSAPS can both improve one's ability to hear sound; they are both wearable, and some of their technology and function is similar. However, the products are different in that only hearing aids are intended to make up for impaired hearing. PSAPs are not intended to make up for impaired hearing. Instead, they are intended for non-hearing-impaired consumers to amplify sounds in the environment for any number of reasons.
Frequency-specific hearing loss is not something that can be mitigated through the amplification of all sound and using an amplifier where a hearing aid should be used can be dangerous. Personal sound amplifying products are designed to boost environmental hearing for people without hearing loss. Some people might use PSAPs as over-the-counter hearing aids to cut costs and avoid spending money on a certified hearing aid, but audiologists and doctors warn against the practice. Hearing aids perform a complex purpose that depends on the wearer, whereas amplifiers boost all sound.
Hearing aids are usually professionally fitted and fine-tuned to the wearer and help mitigate hearing loss by boosting certain frequencies. Amplifiers simply make things louder, regardless of the frequency or volume. While hearing aids are tailored to hard of hearing people, PSAPs are meant to be used by people with a full range of hearing.
We note that the Food and Drug Administration regulates hearing aids in the United States.[18] Under the FDA Reauthorization Act of 2017, Section 709, Congress outlined certain requirements and set forth a process to establish a separate category of over-the-counter (OTC) hearing aids and the requirements that apply to them. While the FDA may impose certain requirements on hearing aids as medical or OTC devices, these requirements are not controlling regarding classification under the HTSUS. "It is well established that statutes, regulations and administrative interpretations relating to 'other than tariff purposes' are not determinative of Customs classification disputes." Amersham Corp. v. United States, 5 CIT 49, 56 (1983). "Articles are classified by the FDA to protect public safety, not as guidance to Customs classification." HQ 085064 (August 24, 1990). See also HQ 962181 (January 13, 1999).
In this case, based on guidance from the EN to heading 9021, HTSUS, the commonly understood definitions of "defect", "disability", "deafness" and "hearing aids", and our own research on the topic, we conclude that the instant devices are not hearing aids of heading 9021, HTSUS. As such, they are not excluded from classification under Section XVI by operation of Note 1(m) to Section XVI.
Heading 8518, HTSUS, provides for headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers. These goods are discussed in Part C of the EN to heading 8518, HTSUS:
Headphones and earphones are electroacoustic receivers used to produce low-intensity sound signals. Like loudspeakers, described above, they transform an electrical effect into an acoustic effect; the means used are the same in both cases, the only difference being in the powers involved.
* * *
The heading also covers sets consisting of a microphone and one or more loudspeakers which may be fitted together. A headphone or earphone may be included with the set for private listening. These sets are designed to be plugged into or connected to a central control system which includes an amplifier. These units may be used by participants at meetings or conferences.
The product at issue in NY N283085 is a retail-ready kit, comprised of a sound amplifier, three plastic earplugs in different sizes, a spare battery, and a plastic storage case. In this case, the earphones provide the essential character of the kit because, although the merchandise amplifies sound, they transmit the amplified sound to the user via the earphones. As such, the correct classification for the hearing amplifier kit is heading 8518, HTSUS, and more specifically, subheading 8518.30.20, HTSUS, by application of GRIs 1, 3(b), and 6. Classification of the subject merchandise under heading 8518, is also consistent with prior CBP rulings where sound amplifying headphones were classified under subheading 8518.30.20, HTSUS. See NY N305242 (August 2, 2019); NY N115718 (August 19, 2010). The products at issue in NY N166443, NY N025447, and NY D80822 are not components of retail sets and are therefore classified under the same provision by application of GRIs 1 and 6.
HOLDING:
By application of GRIs 1, 3 (b) and 6, the hearing amplification kit described in NY N283085 is classified under heading 8518, HTSUS, subheading 8518.30.20, HTSUS, which provides for "Microphones and stands therefor; loudspeakers, whether or not mounted in their enclosures; headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers; audio-frequency electric amplifiers; electric sound amplifier sets; parts thereof: Headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers: Other." The devices described in NY N166443, NY N025447, and NY D80822 are classified under the same provision by application of GRIs 1 and 6. The column one, general rate of duty for merchandise of this subheading is free.
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 on the internet at https://hts.usitc.gov/current.
EFFECT ON OTHER RULINGS:
NY N283085, N166443, N025447, and D80822, dated February 28, 2017, May 31, 2011, April 18, 2008, and August 11, 1998, respectively, are hereby REVOKED.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
cc: John Bessich
Follick & Bessich
33 Walt Whitman Road, Suite 310
Huntington Station, NY 11746
Ms. Roxanne Peiffer
Norman G. Jensen Inc.
3050 Metro Drive, Ste 300
Minneapolis. MN 55425
Mr. James Shaw
Panasonic Logistics Company of America
2 Panasonic Way
Secaucus, NJ 07094
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[1] N166443, dated May 31, 2011, classified a Personal Sound Amplifier under subheading 9021.40.00, HTSUS.
[2] N025447, dated April 18, 2008, classified products referred to as "PockeTalkers" under subheading 9021.40.00, HTSUS.
[3] D80822, dated August 11, 1998, classified an Assistive Listening Device under subheading 9021.40.00, HTSUS.
[4] https://www.merriam-webster.com/dictionary/defect (last visited July 25, 2024).
[5] https://www.merriam-webster.com/dictionary/disability (last visited July 25, 2024).
[6] https://www.merriam-webster.com/dictionary/deafness (last visited July 25, 2024).
[7] https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss (last visited July 25, 2024).
Also see a table showing a common way to classify hearing loss at https://www.asha.org/public/hearing/Degree-of-Hearing-Loss/ (last visited July 25, 2024).
[8] https://www.washington.edu/doit/how-are-terms-deaf-deafened-hard-hearing-and-hearing-impaired-typically-used (last visited July 25, 2024).
[9] https://dictionary.cambridge.org/us/dictionary/english/deafness (last visited July 25, 2024).
[10] https://www.cdc.gov/ncbddd/hearingloss/types.html (last visited July 25, 2024).
[11] https://www.healthyhearing.com/help/hearing-aids (last visited July 25, 2024).
[12] https://www.healthyhearing.com/report/47717-Digital-hearing-aid-history (last visited July 25, 2024). https://www.hearingaidmuseum.com/gallery/General_Info/GenInfoMisc/info/generalinfo-assistivedevices.htm (last visited July 25, 2024).
[13] https://www.healthyhearing.com/help/assistive-listening-devices/fm-systems (last visited July 25, 2024).
[14] https://www.healthyhearing.com/help/assistive-listening-devices (last visited July 25, 2024).
See also https://www.hearingaidmuseum.com/gallery/Miscellaneous/Assistive%20Devices/index-asstdev.htm (last visited July 25, 2024).
[15]https://www.hearingaidmuseum.com/gallery/Miscellaneous/Assistive%20Devices/Sonic%20Technology/index-sonictechnology.htm (last visited July 25, 2024).
[16] https://www.miracle-ear.com/hearing-aid-technology/psap-hearing-aids-differences (last visited July 25, 2024).
[17] See, e.g., https://www.connecthearing.com/blog/hearing-loss/what-the-new-otc-hearing-aid-law-means-for-you/; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products-draft-guidance; and https://www.signia-hearing.com/blog/the-difference-between-hearing-amplifiers-hearing-aids/; https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know (all last visited July 25, 2024).
[18] See 21 CFR 801.420-21.