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ReSound Nexia - February 2024

Bio-logic's Ear Muffin™ Receives FDA 510(K) Clearance For Use With Natus® ALGO®Screeners


MUNDELEIN, Ill./PRNewswire/ -- Bio-logic Systems Corp. (Nasdaq: BLSC) announced today that it has received 510(k) clearance from the United States Food and Drug Administration ('FDA') to market its Ear Muffin™ for use in conjunction with the installed base of Natus Medical Inc.'s ALGO® newborn hearing screeners. With the FDA 510(k) clearance for its Ear Muffin™, Bio-logic can now offer customers using the ALGO® screener a competitively priced alternative to the Natus® Ear Coupler® disposable earphone.

Roderick G. Johnson, president and chief operating officer, commented, 'We intend to aggressively pursue a significant portion of this $15 million product segment by offering a high quality, lower cost disposable option to hospitals and buying groups that until now have had only one source of supply and pricing. We believe that with the Ear Muffin™, Ear Coupler® users may realize savings of up to 30 percent on their disposables.'

Bio-logic launched the Ear Muffin™ disposable for its ABaer™ infant hearing screening system in July 2001, and competes directly with the Natus® ALGO® screener and Ear Coupler® disposable. The Ear Muffin™ broadens the Company's infant screening line by adding a disposable over-the-ear earphone for delivering sound stimuli to an infant's ear canal. The ABaer™ provides all of the hearing screening technologies in one compact system and can be used with a range of disposables from the patented Tree Tip® to the new Ear Muffin™.

Johnson added, 'This is a significant milestone for the Company. We have the broadest offering to serve the newborn hearing screening and diagnostic market with OAE (AuDX®) and automated ABR (ABaer™) infant screeners, and a diagnostic system (Navigator® Pro) for referred babies who need full diagnostic ABR testing to confirm and define the hearing loss so that appropriate follow-up, including fitting of hearing aids if needed, can be initiated. As more states and countries mandate newborn hearing screening and with a potential $140 million screening market, we are uniquely positioned to offer a total cost effective screening solution in one system, along with the broadest range of disposable options to meet the needs of hospitals and clinics.'

Bio-logic Systems Corp., headquartered in Mundelein, IL, designs, develops, assembles and markets computer-based electrodiagnostic systems and related disposables for use by hospitals, clinics, universities and physicians. The systems conduct tests that are typically used by medical practitioners to aid in the screening and diagnosis of certain audiological and hearing disorders, brain disorders and tumors, and neurological, sleep and sensory disorders. For more information please visit our Web site at .

The statements which are not historical facts contained in this release are forward looking statements that involve risks and uncertainties, including, but not limited to, product demand and market acceptance risks, the effect of economic conditions, the impact of competitive products and pricing, production, commercialization and technological difficulties, capacity and supply constraints or difficulties, and other risks detailed in the company's filings with the Securities and Exchange Commission.

Signia Xperience - July 2024

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