Item 8.01 Other Events.
As previously disclosed, on September 21, 2021, Eargo, Inc. (the "Company") was
informed that it was the target of an ongoing criminal investigation by the U.S.
Department of Justice (the "DOJ") related to insurance reimbursement claims the
Company submitted on behalf of its customers covered by various federal employee
health plans under the Federal Employee Health Benefits program. On January 4,
2022, the DOJ confirmed to the Company that the investigation has been referred
to the Civil Division of the DOJ and the U.S. Attorney's Office for the Northern
District of Texas and the criminal investigation is no longer active. The
Company is continuing to cooperate with the investigation.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. All statements
other than statements of historical fact contained in this report are
forward-looking statements, including statements regarding the status of the
criminal investigation and the Company's cooperation with the investigation.
Forward-looking statements are not guarantees of future performance and are
subject to risks, uncertainties and assumptions that could cause actual results
and events to differ materially from those anticipated, including, but not
limited to, risks, uncertainties and assumptions related to: the outcomes of the
DOJ investigation and third-party payor audits; potential related penalties and
fines that may ensue as a result of the DOJ investigation, the third-party payor
audits and/or any other action that may arise therefrom; recoupments of previous
claims paid as a result of the DOJ investigation, the third-party payor audits
and/or any other action that may arise therefrom; the impact of the DOJ
investigation and third-party payor audits on the Company's business and results
of operations; the Company's expectations concerning additional orders by
existing customers; the Company's expectations regarding the potential market
size and size of the potential consumer populations for its products and any
future products, including insurance coverage of Eargo hearing aids; the
Company's ability to release new hearing aids and the anticipated features of
any such hearing aids; developments and projections relating to the Company's
competitors and its industry, including competing products; the Company's
ability to maintain its competitive technological advantages against new
entrants in its industry; the pricing of the Company's hearing aids; the
Company's expectations regarding the ability to make certain claims related to
the performance of its hearing aids relative to competitive products; the
Company's expectations with regard to changes in the regulatory landscape for
hearing aid devices, including the anticipated implementation of a pending
over-the-counter hearing aid regulatory framework; and the Company's estimates
regarding the COVID-19 pandemic, including but not limited to, its duration and
its impact on the Company's business and results of operations. These and other
risks are described in greater detail under the section titled "Risk Factors"
contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form
10-Q and other filings with the U.S. Securities and Exchange Commission. Any
forward-looking statements in this Current Report on Form 8-K are made pursuant
to the Private Securities Litigation Reform Act of 1995, as amended, are based
on current expectations, forecasts and assumptions, and speak only as of the
date of this report. Except as required by law, the Company undertakes no
obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise.
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