Are custom-molded ear plugs sold to protect hearing during loud work or performances exempt from New York sales tax as a 'medical device'?

Plain-English summary

Marilyn Navia makes custom-molded ear plugs that provide hearing protection to musicians, construction workers, and others exposed to high noise levels — some customers may already have some hearing loss, others may not. She travels into New York to fit and construct the ear plugs in person (no mail-order or Internet sales), and asked whether her product qualifies for New York's exemption for medical equipment.

New York exempts medical equipment used in the cure, mitigation, treatment, or prevention of illness or disease, or to correct/alleviate physical incapacity — but the regulations add a real limiting test: to qualify, the equipment must be primarily and customarily used for medical purposes and must not be generally useful to people without any illness, injury, or physical incapacity. The Department held Navia's ear plugs fail that test: protective devices don't become medical equipment merely because they prevent an injury (here, hearing loss) — the fact that some buyers may already have hearing loss doesn't matter, because the same ear plugs are equally suitable and marketed for use by healthy individuals with no medical condition at all. New York's own published guidance (Publication 822) already lists ear plugs among the specifically taxable devices. So Navia's ear plugs are fully subject to sales tax, regardless of the genuine hearing-protection benefit they provide.

The Department didn't stop there, though — it flagged two narrower, separate exemptions that can still apply to the exact same product depending on who's buying it. If a farm-production customer buys the ear plugs for use as personal protective equipment while engaged in qualifying farm production, that purchase is exempt under the farming exemption (ear protection is specifically listed as an example of qualifying farm safety equipment). And if a manufacturer buys the ear plugs for its own production employees to wear on the job, that purchase can qualify under the separate manufacturing-supplies exemption — though if the manufacturer turns around and sells the ear plugs to its own employees, it must collect state and local tax on that resale. Each of these exemptions requires its own certificate (Form ST-125 for farmers, ST-121 for manufacturers buying for their own use, or ST-120 if a manufacturer is buying for resale to employees) within 90 days of the sale.

What this means for you

Sellers of protective/safety equipment marketed with health benefits

Preventing injury isn't the same as treating an existing medical condition — protective equipment (ear plugs, safety glasses, and similar items) generally won't qualify for the medical-equipment exemption just because it protects a body part from harm, unless it's primarily and customarily used only by people who already have an illness or impairment.

Sellers whose customers include both consumers and businesses

The same product can have different tax treatment depending entirely on who's buying it and why — track whether a given sale is to an ordinary retail customer (taxable), a qualifying farm-production buyer (exempt with Form ST-125), or a manufacturer buying supplies for its own production employees (exempt with Form ST-121, but taxable again if resold to employees).

Accountants and tax professionals

This is a clean, short citation for the "primarily and customarily used for medical purposes, not generally useful absent illness/injury" test under 20 NYCRR § 528.4(e)(2) — useful for any protective-equipment product (ear plugs, braces, supports) marketed partly on health/injury-prevention grounds.

Common questions

Q: Does a product become a tax-exempt medical device just because it prevents an injury like hearing loss?
A: No — the exemption requires the item be primarily and customarily used for medical purposes and not generally useful to healthy people. Protective/preventive equipment usable by anyone doesn't meet that bar just because it also benefits people with an existing condition.

Q: Can the same ear plugs be tax-exempt in some sales and taxable in others?
A: Yes — sold to an ordinary consumer, they're taxable; sold to a qualifying farm-production customer as protective equipment, or to a manufacturer for its own production employees' use, they can be exempt under separate, unrelated exemptions.

Q: What certificate does a buyer need to claim one of these alternate exemptions?
A: A farm-production buyer uses Form ST-125 (Farmer's and Commercial Horse Boarding Operator's Exemption Certificate); a manufacturer buying for its own employees' use uses Form ST-121 (Exempt Use Certificate); a manufacturer buying for resale to employees uses Form ST-120 (Resale Certificate) but must then collect tax when reselling to those employees.

Citations and references

Statutes and regulations:

• Tax Law § 1105(a) (retail sales tax); § 1105-B(a) (production parts/tools/supplies exemption)
• Tax Law § 1110(a) (compensating use tax)
• Tax Law § 1115(a)(3) (medical equipment/drugs exemption); § 1115(a)(6) (farm production exemption)
• 20 NYCRR § 528.4 (medical equipment exemption); § 528.7(e) (farm personal protective equipment); § 528.13 (production supplies exemption)
• Publication 852 (Sales Tax Information for Manufacturers..., 12/97); Publication 822 (Taxable Status of Medical Equipment and Supplies, 6/01)

Prior rulings and cases referenced:

• Robert C. Ferber, TSB-A-88(51)S
• Craftmatic Comfort Manufacturing Corp. v. New York State Tax Commission, 69 NY2d 141
• Russell J. Shapiro, TSB-A-93(39)S

Source

• Landing page: https://www.tax.ny.gov/pubs_and_bulls/advisory_opinions/sales_ao_2002.htm
• Opinion: https://www.tax.ny.gov/pdf/advisory_opinions/sales/a02_56s.pdf

Original ruling text

New York State Department of Taxation and Finance

Office of Tax Policy Analysis
Technical Services Division

TSB-A-02(56)S
Sales Tax
November 7, 2002

STATE OF NEW YORK
COMMISSIONER OF TAXATION AND FINANCE
ADVISORY OPINION

PETITION NO. S020319A

On March 19, 2002, the Department of Taxation and Finance received a Petition for
Advisory Opinion from Marilyn Navia, 10265 NW 56 Street, Miami, FL 33178. Petitioner, Marilyn
Navia, provided additional information pertaining to the Petition on May 21, 2002.
The issue raised by Petitioner is whether the custom-made ear plugs she sells are considered
to be medical devices which would qualify for exemption from New York State and local sales or
compensating use tax under Section 1115(a)(3) of the Tax Law.
Petitioner submitted the following facts as the basis for this Advisory Opinion.
Petitioner is in the business of making custom ear plugs which are used to provide hearing
protection to individuals engaged in high noise level activities, such as musicians, construction
workers, and those who work around loud machinery. Petitioner’s customers may or may not have
already experienced a hearing loss.
Petitioner is located outside of New York State, but makes trips into New York to fit and
construct the ear plugs for her customers. Petitioner does not sell her product by mail-order or the
Internet.
Applicable Law and Regulations
Section 1105(a) of the Tax Law imposes a tax on “[t]he receipts from every retail sale of
tangible personal property, except as otherwise provided in this article.”
Section 1105-B(a) of the Tax Law provides:
Receipts from the retail sales of parts with a useful life of one year or less,
tools and supplies for use or consumption directly and predominantly in the
production of tangible personal property, gas, electricity, refrigeration or steam for
sale by manufacturing, processing, generating, assembling, refining, mining or
extracting shall be exempt from the tax imposed by subdivision (a) of section eleven
hundred five of this article.
Section 1110(a) of the Tax Law provides, in part:
Except to the extent that property or services have already been or will be
subject to the sales tax under this article, there is hereby imposed on every person a

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use tax for the use within this state . . . except as otherwise exempted under this
article, (A) of any tangible personal property purchased at retail. . . .
Section 1115(a) of the Tax Law exempts from the sales tax imposed by Section 1105(a) of
the Tax Law and from the compensating use tax imposed under Section 1110:
*

*

*

(3) Drugs and medicines intended for use, internally or externally, in the cure,
mitigation, treatment or prevention of illnesses or diseases in human beings, medical
equipment (including component parts thereof) and supplies required for such use
or to correct or alleviate physical incapacity, and products consumed by humans for
the preservation of health but not including cosmetics or toilet articles
notwithstanding the presence of medicinal ingredients therein or medical equipment
(including component parts thereof) and supplies, other than such drugs and
medicines, purchased at retail for use in performing medical and similar services for
compensation.
*

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*

(6)(A) Tangible personal property, whether or not incorporated in a building
or structure, for use or consumption predominantly either in the production for sale
of tangible personal property by farming or in a commercial horse boarding
operation, or in both.
Section 528.4 of the Sales and Use Tax Regulations provides, in part:
(a) Exemption. (1) Drugs and medicines intended for the use, internally or
externally in the cure, mitigation, treatment or prevention of illnesses or diseases in
human beings, medical equipment (including component parts thereof) and supplies
required for such use or to correct or alleviate physical incapacity, and products
consumed by humans for the preservation of health are exempt.
*

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*

(e) Medical equipment. (1) Medical equipment means machinery, apparatus
and other devices . . . which are intended for use in the cure, mitigation, treatment
or prevention of illnesses or diseases or the correction or alleviation of physical
incapacity in human beings.

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(2) To qualify, such equipment must be primarily and customarily used
for medical purposes and not be generally useful in the absence of illness, injury or
physical incapacity. (Emphasis added)
*
Example 2:

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A medical patient purchases an air conditioner to be used to
lower air temperature to alleviate his illness. Since an air
conditioner is nonmedical in nature, it is not exempt from the
tax.

Section 528.7(e) of the Sales and Use Tax Regulations provides, in part:
Personal protective equipment. (1) Personal protective equipment purchased
by a person engaged in farming for such person’s own use or for use by such
person’s employees and used or consumed . . . predominantly in production for sale
of tangible personal property by farming (“farm production”) will be exempt from
the New York State and local sales and compensating use taxes including the taxes
imposed in New York City under section 1107 of the Tax Law.
(2) Personal protective equipment means tangible personal property
designed to protect an individual against the possible hazards of processes,
environmental hazards, chemical hazards or mechanical hazards encountered by the
user while engaged directly in farm production, which hazards may cause injury to
or impairment in the function of any part of the body through absorption, inhalation
or physical contact. . . .
(3) Following are examples of personal protective equipment that may
qualify for exemption when used or consumed . . . predominantly in farm production.
...
*

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*

(ii) Ear protection. Protective devices for the ears where there is a danger
from any source that could cause physical injury to the ear or cause impairment or
loss of hearing.
Section 528.13 of the Sales and Use Tax Regulations provides, in part:
(a) Exemption. (1) Exemption from statewide tax. An exemption is allowed
from the tax imposed under subdivisions (a) and (c) of section 1105 of the Tax Law,
and from the compensating use tax imposed under section 1110 of the Tax Law, for
receipts from sales of the following:

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*

*

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(iii) (a) Parts with a useful life of one year or less, tools or supplies for use
or consumption directly and predominantly in the production of tangible personal
property, gas, electricity, refrigeration or steam for sale by manufacturing,
processing, generating, assembling, refining, mining or extracting.
*

*

*

(e)(3) The term supply means an item of tangible personal property . . . used
or consumed in production, whose use is incidental to such production, or which is
expendable.
New York State Department of Taxation and Finance Publication
852 (12/97), Sales Tax Information For Manufacturers, Processors, Generators,
Assemblers, Refiners, Miners and Extractors, and Other Producers of Goods and
Merchandise, provides, in part:
Safety apparel and safety supplies (such as uniforms, hair coverings, safety shoes, gloves,
and eye shields) that are indispensable to production, and that are furnished by the manufacturer to
the manufacturer’s employees, are exempt from both the state and local sales and use taxes. An
Exempt Use Certificate, Form ST-121, may be issued by the manufacturer to the supplier for the tax­
exempt purchase of these items. If a manufacturer sells the safety apparel and supplies to
its employees, the manufacturer should issue a Resale Certificate, Form ST-120, to the supplier for
purchases of these items. Both state and local taxes must be collected when the manufacturer sells
the safety apparel or supplies to its employees.
Opinion
Petitioner sells custom ear plugs which are used to provide hearing protection to individuals
exposed to loud noise. Petitioner contends that the custom ear plugs should be exempt from sales
and use tax as qualifying medical devices under Section 1115(a)(3) of the Tax Law.
Section 1115(a)(3) of the Tax Law exempts medical equipment used in the cure, mitigation,
treatment or prevention of illnesses or diseases, or to correct or alleviate physical incapacity, in
human beings. Protective devices such as Petitioner’s custom ear plugs do not qualify as medical
devices merely because they prevent injury (hearing loss). See Robert C. Ferber, Adv Op Comm
T&F, October 13, 1988, TSB-A-88(51)S. The fact that the ear plugs may be used by an individual
who already has a hearing loss does not detract from the fact that they are also suitable for use
by healthy individuals. See Craftmatic Comfort Manufacturing Corp. V. New York State Tax
Commission 69 NY2nd 141; Russell J. Shapiro, Adv Op Comm T&F, June 21, 1993,
TSB-A-93(39)S. Petitioner’s custom ear plugs are not primarily or customarily used for medical

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purposes as required by Section 528.4(e)(2) of the Sales and Use Tax Regulations, but rather are
used without regard to the medical condition of an individual. Moreover, due to the nonmedical
nature of ear plugs, they are included as taxable devices in New York State Department of Taxation
and Finance Publication 822 (6/01), Taxable Status of Medical Equipment and Supplies, Prosthetic
Devices, and Related Items, page 6. Accordingly, notwithstanding their obvious usefulness in
protecting their users from injury, Petitioner’s custom ear plugs do not qualify as medical devices
within the meaning of Section 1115(a)(3) of the Tax Law and are subject to sales tax. See Robert
C. Ferber, supra.
It is noted that even though Petitioner’s custom ear plugs do not qualify as exempt medical
devices, they do fall within the exemption provided in Section 1115(a)(6) of the Tax Law if
purchased by a customer for use or consumption predominantly in farm production. See Section
528.7(e)(3)(ii) of the Sales and Use Tax Regulations. They also fall within the exemption provided
in Section 1105-B of the Tax Law if purchased by a manufacturer for use or consumption directly
and predominantly in production. (See Section 528.13(e)(3) of the Sales and Use Tax Regulations.
See also Publication 852, supra.) If the manufacturer sells the custom ear plugs to its employees,
the manufacturer may purchase them for resale from Petitioner, and must collect both state and local
taxes when it sells the custom ear plugs to its employees. To claim these exemptions, Petitioner’s
customers must present her with a
Farmer’s and Commercial Horse Boarding Operator’s
Exemption Certificate, Form ST-125, an Exempt Use Certificate, Form ST-121, or a Resale
Certificate, Form ST-120, respectively, within 90 days of the date of the sale.

DATED: November 7, 2002

NOTE:

/s/
Jonathan Pessen
Tax Regulations Specialist IV
Technical Services Division

The opinions expressed in Advisory Opinions are
limited to the facts set forth therein.