FDA proposes new category of OTC hearing aids

This column reviews details on recent recalls, alerts, and approvals.

Recalls and warnings

A class I recall of the Pipeline Flex Embolization Device by Medtronic due to a risk of the delivery system's wire and tubes fracturing and breaking off during stent placement, retrieval, or movement inside a patient. There have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to the recall. A total of 8,825 recalled devices were distributed from April 18, 2019, to Aug. 13, 2020.

A class I recall of specific lots of the ZOOM 71 Reperfusion Catheter by Imperative Care Inc. due to an increased risk of the catheter breaking at the distal tip during use, such as when it is retracted forcefully. There have been nine reports of serious injuries and no reported deaths for this issue. The recall includes 3,098 devices distributed from Sept. 23, 2020, to Aug. 9, 2021.

A class I recall of certain CardioSave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs by Datascope/Getinge/Maquet due to the risk of the battery failing and having a shortened run time. The problem is due to customers receiving substandard batteries that failed to meet performance specifications. There have been six complaints and no reports of related injuries or deaths. The recall includes 137 battery packs distributed from Sept. 23, 2017, to Aug. 17, 2021.

A class I recall of prefilled syringes in custom convenience kits by Aligned Medical Solutions due to the potential for the syringe plunger to draw back after the air has been expelled and reintroduce air into the syringe. There have been 42 reports of plunger retraction and introduction of air into the syringe; however, no related injuries or deaths have been reported. The recall includes Cardinal Health Monoject Flush Prefilled Syringes (0.9% sodium chloride) placed into 9,378 kits distributed from Jan. 23 to Oct. 19, 2020.


A proposed rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. It would also amend existing rules that apply to hearing aids for consistency with the new OTC category, repeal the conditions for sale of hearing aids, and address state regulation of hearing aids. The OTC category, when finalized, would apply to certain air-conduction hearing aids for adults with perceived mild to moderate hearing loss; hearing aids would be prescription devices for those with severe hearing loss and those younger than age 18 years.

A safety communication informing clinicians and patients about the potential for overdose when using ENFit low-dose tip syringes. The FDA provided recommendations to promote the safe use of the syringes and optimize dose accuracy, such as ensuring the syringe is free of air bubbles by tapping or flicking the tip before administering the medication and using a filling adapter to prevent fluid and medications from entering the moat area of the syringe tip. When using these recommended steps, the dose accuracy of the syringes is equivalent to that of traditional syringes, the FDA said.

COVID-19 updates

Amended emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all adults after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The new EUAs expand the use of booster doses of both vaccines to include all individuals ages 18 years and older at least six months after completion of the primary Moderna or Pfizer-BioNTech COVID-19 vaccine series or at least two months after primary vaccination with the Johnson & Johnson (Janssen) COVID-19 vaccine.

A revised EUA for bamlanivimab and etesevimab, administered together, to include an emergency use as postexposure prophylaxis for COVID-19 in certain patients. The drug combination is authorized in patients ages 12 years and older who weigh at least 40 kg and are at high risk for progression to severe COVID-19, including hospitalization or death. It is not authorized for pre-exposure prophylaxis.

A class I recall of the software for the Alinity m SARS-CoV-2 AMP Kit and the Alinity m Resp-4-Plex AMP Kit by Abbott Molecular Inc. due to potential false-positive SARS-CoV-2 test results. The recall is to correct the software; the kits can continue to be used after the software has been updated. If used before the software correction, positive results should be treated as presumptive.

A recall of certain lots of the COVID-19 Home Test by Ellume due to a higher-than-acceptable rate of false-positive test results for SARS-CoV-2. The reliability of negative test results is not affected. There have been 35 reports of false-positive results sent to the FDA. No deaths have been reported. The recall includes more than 2.2 million antigen tests distributed from April 13 to Aug. 26, 2021.

Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include dexmedetomidine injection USP (200 µg/2 mL), propofol injectable emulsion USP (200 mg/20 mL [10 mg/mL], 500 mg/50 mL [10 mg/mL], and 1,000 mg/100 mL [10 mg/mL] in single-use vials), and succinylcholine chloride injection USP (200 mg/10 mL).


The first interchangeable biosimilar to adalimumab (Humira). Adalimumab-adbm (Cyltezo), originally approved in August 2017, is both biosimilar to and interchangeable with adalimumab for the following indications in adult patients: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and moderate to severe chronic plaque psoriasis. The drug is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. It is administered subcutaneously under the guidance of a physician. The most serious known side effects are infections and malignancies, and the most common expected adverse reactions are upper respiratory and sinus infections, injection site reactions, headache, and rash. The drug carries a boxed warning alerting clinicians and patients about an increased risk of serious infections that may lead to hospitalization or death.

First generic drug approvals

Paroxetine oral suspension (10 mg [base]/5 mL) to treat adult patients with major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and post-traumatic stress disorder. (Brand name: Paxil)

Vortioxetine tablets (5 mg, 10 mg, and 20 mg) to treat adult patients with major depressive disorder. (Brand name: Trintellix)

Zolmitriptan nasal spray USP (2.5 mg and 5 mg) for the acute treatment of migraine with or without aura in patients ages 12 years and older. (Brand name: Zomig)

Note: The FDA states that drugs are not always commercially available immediately after approval.