Interpretation Response #20-0078

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 04/16/2021

Company Name: Starkey Laboratories, Inc.

Individual Name: Dawn Gardner

Location State: MN Country: US

View the Interpretation Document

Response text:

April 16, 2021

Dawn Gardner
Starkey Laboratories, Inc.
6700 Washington Ave S
Eden Prairie, MN 55344

Reference No. 20-0078

Dear Ms. Gardner:

This letter is in response to your September 16, 2020, letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the description of a lithium battery-powered device. In your letter, you state that your company manufactures a product comprised of a set of hearing aids and a portable case that contains a lithium ion battery. You state that the case: (1) may be used to provide power to the set of hearing aids; and (2) performs additional functions such as:

• Running diagnostic testing to identify any faults, reading the charge level of hearing aid cells, and protecting hearing aid cells from overcharge;
• Turning the hearing aids on and off (hearing aids will not turn on without the case);
• Triggering connectivity of the hearing aids;
• Resetting functionality of the case and hearing aids through the push of a reset button; and
• Protecting the hearing aids from mechanical abuse and humidity during storage or transportation.

Additionally, you state that your company has reviewed previously-issued letters of interpretation by PHMSA regarding hearing aid products (e.g., Ref. No. 19-0134), and your understanding is that your device is different because the case has more functionality than a typical back-up power supply solely used to power a device. As such, you believe the hearing aid case is "equipment" per § 173.185 and that the case should be described for transport as "UN3481, Lithium ion batteries contained in equipment, 9."

In accordance with § 173.22 of the HMR, it is the shipper's responsibility to properly classify and describe a hazardous material. This Office does not perform that function. However, in consideration of the information you have provided, it is the opinion of this Office that your understanding is not correct. Section 173.185 defines "equipment" as the device or apparatus for which the lithium cells or batteries will provide electrical power for its operation. In this instance, the equipment being powered are the hearing aids. While the case performs some additional functions, the primary function of the case is to provide power to external pieces of equipment (i.e., the set of hearing aids). As such, the most appropriate shipping description to describe the portable case if shipped without the hearing aids is "UN3480, Lithium ion batteries, 9." The set of hearing aids if shipped separately without the case should be described as "UN3481, Lithium ion batteries contained in equipment, 9." Lastly, if the hearing aids are shipped with the case, the appropriate description is "UN3481, Lithium ion batteries packed with equipment, 9."

I hope this information is helpful. Please contact us if we can be of further assistance.

Sincerely,

Dirk Der Kinderen
Chief, Standards Development Branch
Standards and Rulemaking Division

173.22, 173.185

Regulation Sections