New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020.

OBJECTIVES: To evaluate new drugs and devices relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. DATA SOURCES: Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. REVIEW
METHODS: Members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA's device and therapeutic approvals. Two independent reviewers assessed the drug's or device's relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature.
CONCLUSIONS: The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology's armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. IMPLICATIONS FOR PRACTICE: New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.

Medical knowledge and technological innovations are expanding at an exponential rate. Such progress allows surgeons to offer promising new therapies and improve on existing ones. However, as the rate of discovery and invention accelerates, it becomes increasingly difficult for busy clinicians to evaluate the evidence and judgments that are critical to deciding how and when to assimilate new innovations into practices. The Medical Devices and Drugs Committee of the American Academy of Otolaryngology–Head and Neck Surgery helps to address this need by reviewing US Food and Drug Administration (FDA) approvals on an annual basis. The FDA has a charge to ensure that only safe and effective drugs and devices enter the market, serving as the gatekeeper for essential and novel therapies that otolaryngologists may bring to patients. This state of the art review critically evaluates drugs and devices approved in the 2020 calendar year.

Methods

Review of FDA approvals was conducted in accordance with procedures previously described by the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee. Publicly available records from the FDA were queried for drug and device approvals or modifications from January 1 to December 31, 2020. For devices, approved 510(k) premarket submissions, premarket authorizations, and de novo products were reviewed.[3-5] FDA databases for ENT (ear, nose, and throat), anesthesia, neurosurgery, and plastic and general surgery were evaluated. Approved novel drugs were also reviewed. Products were then prioritized by relevance, novelty, and impact to the specialty, as assessed by 2 independent reviewers, at least 1 of whom had fellowship training in the applicable subspecialty or commensurate expertise ( , ). If needed, companies were contacted to clarify details and to secure permission to share images of their products.

Figure 1.

Data collection to state of the art review inclusion. FDA, Food and Drug Administration. Refer to for screening criteria.

Table 1.

Criteria for Screening FDA-Approved Drugs and Devices.

Lack of relevance	Lack of novelty or impact
• A device or drug not applicable to the scope of typical practice in otolaryngology• An approval that does not address a defined need or improve care in otolaryngology	• Renewal of a previous FDA approval• Incremental change in an existing product or minor update to an existing approval (eg, for changes in supply chain)• Rebranding or introduction of a non–first-in-class that does not differentiate from a previously approved product (eg, new hyaluronic acid filler)

Abbreviation: FDA, Food and Drug Administration.

All novel drugs and medical devices identified as relevant to otolaryngology were reviewed. Renewals of existing products, incremental product updates, and products not applicable to otolaryngology practice were excluded. A total of 53 novel drugs were approved by the FDA during the 2020 calendar year, of which 10 were relevant to otolaryngology. In addition, 1094 devices from relevant FDA committees were approved (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology), of which 17 were relevant to otolaryngology ( ). The scientific evidence supporting each device or therapeutic varied widely, ranging from case series reported exclusively to the FDA to several large peer-reviewed randomized controlled trials. Therapies relevant to the COVID-19 pandemic were excluded, as these products require a dedicated comprehensive review.

Table 2.

Otolaryngology-Relevant Devices and Drugs Approved by the Food and Drug Administration in 2020 by Subspecialty.

	Devices (n = 17)	Drugs (n = 10)
Otology	Nucleus 24 Cochlear ImplantOrion ChairTRV ChairColibri Endoscope	None
Laryngology	None	berotralstat (Orladeyo)
Head and neck/endocrine	None	tazemostat (Tazverik)selumetinib (Koselugo)selpercatinib (Retevmo)pralsetinib (Gavreto)teprotumumab (Tepezza)tirbanibulin (Klisyri)
Plastics	Hemoblast BellowsStarPore	oxymetazoline (Upneeq)
Rhinology	NovapakDrillCut-XTruDiTruDi CuretteStryker ENT Navigation–Universal HeadrestTGS GuidewireXprESS LoProfile ENT Dilation SystemClearPath Nasal Balloon Catheter	None
Pediatrics	Hummingbird TTSBizact	None
Sleep	None	None
General	Otoset	rimegepant (Nurtec ODT)eptinezumab (Vyepti)

Refer to the text for details about each product.

Discussion

Otology

Expanded Cochlear Implant Indications

The Nucleus 24 Cochlear Implant System (Cochlear Americas) was originally approved by the FDA in 1998 to restore auditory sensation to adults and children via electrical stimulation of the auditory nerve. In March 2020, the FDA approved expanded indications for this device to include infants between 9 and 12 months old with bilateral profound sensorineural hearing loss. Previously, it was approved only for patients ≥12 months old. The expanded approval relied on (1) a systematic review of 49 peer-reviewed articles of cochlear implantation from 750 patients <12 months in age provided to the FDA and (2) an analysis of 84 pediatric subjects between 9 and 12 months old who received a Nucleus 24 cochlear implant from 1 of 5 cochlear implant centers across the United States and Canada. The systemic review demonstrated comparable safety of cochlear implantation for patients younger and older than 12 months, and individuals implanted at <12 months of age received significant benefit in speech and language development. The 84-subject study demonstrated low adverse event rates: 2.4% cerebral spinal fluid leak, 2.4% temporary facial weakness, 2.4% infection, 7.1% minor postoperative complication, 3.6% minor skin irritation, 3.6% otitis media, 2.4% seroma, and 7.1% temperature dysregulation during the procedure. A majority of these adverse events, 26 of 28, resolved without major surgical or medical intervention. There were no reports of postoperative meningitis, device failures, device extrusions, or other serious device malfunctions.

Orion Chair for Vestibular Evaluation

The Orion Chair (Interacoustics) is a new rotatory chair for vestibular assessment. An attractive optional feature is the ability to recline the chair, allowing videonystagmography for other vestibular tests within the same device and space. The chair also allows off-axis rotational acceleration to be studied. This product competes with the Neuro-Kinetics NOTC system, which was the only similar device on the market for years.

TRV Chair for Benign Paroxysmal Positional Vertigo

The TRV Chair, also by Interacoustics, is designed for benign paroxysmal positional vertigo testing and rehabilitation. This chair effectively replaces the Epley Omniax Chair (Vesticon), whose business recently withdrew from the market. Unlike the Omniax Chair, the TRV Chair is manually operated, which eliminates the risk of motor failures seen in the Omniax.

The TRV Chair has been favorably compared to the Omniax. In a recent study, Pedersen and colleagues diagnosed and treated 81 patients with refractory benign positional vertigo using the TVR Chair. Successful treatment within this population was found in 92% of patients, requiring an average of 2.2 (SD, 1.7) treatments. Ultimately, these chairs do not improve the efficacy of the canalith repositioning maneuver, but they do allow repositioning maneuvers in patients who cannot easily lie down and turn the neck.

Colibri Endoscope System for Otologic Surgery

In the evolving field of endoscopic ear surgery, one challenge has been the need to change between dissecting instruments and a suction with a single operative hand. The Colibri ear endoscope system (3NT Medical Ltd) places a suction through a working channel around a disposable endoscope ( ), allowing the suction and endoscope to be combined. This suction can rotate, helping to approximate 2-handed surgery and thereby addressing one of the frequent criticisms of otoendoscopic surgery. The length is 64 mm, approximating other otologic instruments. The endoscope is at a 0° angle and is 2.2 mm in optical diameter. This reduces some image quality when compared with larger-diameter endoscopes, but some surgeons may find this a worthwhile trade since it reduces instrument exchanges.

Figure 2.

Colibri endoscope system for otologic surgery.

The Colibri ear endoscope is one of many single-use endoscopes entering the market this year but the only one meriting committee review (the other 2 single-use endoscopes reviewed were principally of pulmonology interest and excluded). In the coming years, novel single-use endoscopes are anticipated across otolaryngology. Single-use products have appeal due to the elimination of infection risk from inadequate cleaning, avoidance of regulatory challenges with processing and storage, and obviating the need for costly scope repairs.[12,13] In one recent study, direct cost assessment between a disposable and reusable video laryngoscope system suggested a saving per use favoring single-use scopes. However, cost is multifactorial and likely varies by the type of endoscope system, life span of the reusable system, and frequency and extent of repairs.

Laryngology

Berotralstat Hydrocholoride for Hereditary Angioedema

Berotralstat (Orladeyo; Biocryst Pharmaceuticals, Inc) is the first oral nonandrogen medication approved for use for hereditary angioedema (HAE). HAE is a rare disease caused by C1 esterase inhibitor deficiency, mediated by overproduction of bradykinin secondary to unregulated kallikrein activity. Bradykinin production leads to vasodilation and vascular permeability and leakage, as well as subsequent swelling of the lips, tongue, and larynx that may precipitate airway emergencies. Berotralstat is a once-daily oral selective kallikrein inhibitor for long-term prophylactic treatment of HAE that has been shown to significantly reduce the frequency of angioedema attacks as compared with placebo. Adverse events are mild, and most typically consist of abdominal pain, nausea, vomiting, diarrhea, and back pain. As a therapeutic, its advantages over existing treatments include oral dosing and requiring no special preparation or storage.

Head and Neck/Endocrine

Tazemetostat for Epithelioid Sarcoma

Epithelioid sarcoma is a rare, locally aggressive soft tissue malignancy that typically arises in the extremities of young adults but rarely occurs in the head and neck.[18-20] Current treatment paradigms usually involve surgery with adjuvant chemotherapy ± radiation therapy. Tazemostat (Tazverik; Epizyme) is an inhibitor of the methyltransferase EZH2, which has aberrantly upregulated activity in most epithelioid sarcomas. In a phase II open-label study of patients with advanced disease that is unresectable, recurrent, or metastatic, tazemostat provided a modest benefit with a 15% objective response rate (all partial response) and a 26% disease control rate (stable or decreasing extent of disease for >32 weeks). Tazemostat is a molecular-targeted therapeutic option for patients with disease refractory to standard treatment and should be considered only within multidisciplinary discussions, ideally at specialized oncology centers with expertise in soft tissue sarcomas.

Selumetinib for Plexiform Neurofibromas in Neurofibromatosis Type 1

Plexiform neurofibromas are pathognomonic of neurofibromatosis type 1 (NF1), occurring in approximately 30% of patients. Plexiform neurofibromas commonly affect cranial nerves and brachial plexus. They may infiltrate into the surrounding soft tissues, resulting in unresectable lesions or high rates of recurrence when resectable. Although usually benign, there is a 5%-10% lifetime risk of malignant transformation, correlating with lesion size. Selumetinib (Koselugo; AstraZeneca) is an oral MEK1/2 inhibitor, which blocks the activity of the RAS-regulated RAF-MEK-ERK pathway. This pathway has been implicated in neurofibroma pathogenesis in NF1 and is activated in several other tumors, including some thyroid carcinomas.[23,24] The SPRINT phase II open-label study of selumetinib in patients with unresectable plexiform neurofibromas demonstrated a 66% objective response rate, defined as at least a 20% tumor volume decrease. The response was durable (82% with response lasting >1 year). Treatment was generally well tolerated, with primary side effects of gastrointestinal upset and rash. Selumetinib is recommended for primary treatment of unresectable plexiform neurofibromas.

Selpercatinib and Pralsetinib for Thyroid Cancer With RET Gene Mutation

Among some thyroid cancers, RET mutations or protein fusions drive tumorigenesis through constitutive activation of the MAPK pathway. RET mutations/fusions are found in 5% to 30% of cases of papillary thyroid carcinoma; in nearly all cases (96%) of familial medullary thyroid carcinoma (MTC), including patients with multiple endocrine neoplasia syndrome types 2A and 2B; and in about 50% of cases of sporadic MTC. MTC is often aggressive, with a high propensity for regional and distant metastatic spread. In patients with locally advanced disease or significant burden of distant metastases, external beam radiation therapy and systemic therapy are considered. Systemic therapy options have been limited, as MTC is not sensitive to radioactive iodine and nonselective multikinase inhibitors have had disappointingly low long-term efficacy due to acquired resistance mutations. Selpercatinib (Retevmo; Loxo Oncology) and pralsetinib (Gavreto; Blueprint Medicines) are novel oral RET kinase inhibitors approved for treatment of RET-mutated locally advanced and metastatic thyroid carcinoma. The phase I/II LIBRETTO-001 and ARROW trials, respectively, demonstrated 62–91% objective response rate with durable response and low side effect profile. Use of a RET-specific inhibitor is now recommended instead of MKIs in advanced RET-driven thyroid carcinomas. Additional clinical trials will help to define whether RET-specific inhibitors may provide benefit in the neoadjuvant setting to reduce the morbidity of surgical treatment for locally advanced disease and/or treat metastatic disease concurrently with locoregional surgery. Low-volume locoregional disease will likely remain primarily treated by surgery, with systemic therapy reserved for locally advanced, recurrent, or metastatic disease.

Teprotumumab for Thyroid Eye Disease

Thyroid eye disease (thyroid ophthalmopathy) affects up to 40% of patients with autoimmune thyroiditis and does not consistently resolve with correction of thyroid dysfunction. Patients may have progressive proptosis and eventual optic nerve compression requiring orbital decompression. Insulin-like growth factor type 1 receptors (IGF-1Rs) have been implicated in thyroid eye disease, and teprotumumab (Tepezza; Horizon Therapeutics, PLC) is a human monoclonal antibody directed against IGF-1R. It is given intravenously once every 3 weeks for 8 doses. In a randomized controlled trial in 83 patients with active thyroid eye disease, 83% in the treatment arm had reduction in proptosis. Common side effects included muscle spasm and alopecia. After FDA approval, there was a single case report of rapidly progressive cognitive decline occurring after the third dose, suggesting a teprotumumab-induced encephalopathy. This finding may prompt caution in prescribing by endocrinologists and ophthalmologists. Teprotumumab is used primarily treat active disease, and chronic thyroid eye disease will likely continue to be treated with surgical decompression.

Tirbanibulin for Actinic Keratosis

Tirbanibulin (Klisyri; Almirall) is a 1% topical ointment indicated for treatment of actinic keratosis (AK) of the face and scalp. AK can present a cosmetic challenge when involving large areas of the face that make surgical excision challenging. Tirbanibulin selectively inhibits cellular tubulin polymerization, interfering with the proliferation of atypical keratinocytes. Reversible binding of tirbanibulin to the colchicine-binding site of β-tubulin explains low clinical toxicity. Double-blind, vehicle-controlled randomized multicenter trials, enrolling 702 patients in 62 sites in the United States (87% men, 13% women, 99% White, 73% aged ≥65 years), established the efficacy of topical application of tirbanibulin to a single predetermined 25 cm2 on the face or scalp with 4 to 8 AKs (once daily for 5 days). Among treated patients, 44% to 54% had complete clearance at day 57 on the face or scalp treatment areas. The most common side effects included application site pruritus or pain.[35,36] Up to 65% of cutaneous squamous cell carcinoma cases originate from AKs; tirbanibulin adds to the armamentarium of therapies to prevent AK progression to squamous cell carcinoma.

Plastic and Reconstructive Surgery

Oxymetazoline for Blepharoptosis

Routinely used for nasal mucosal vasoconstriction and decongestion, oxymetazoline recently became the first FDA-approved pharmacologic treatment for acquired blepharoptosis. Marketed as Upneeq (oxymetazoline hydrochloride ophthalmic solution 0.1%; RVL Pharmaceuticals, Inc), the topical drops are indicated for acquired ptosis, which often results from impairment of the Müller’s muscle that elevates the eyelid in conjunction with the levator superioris. In clinical trials of 360 subjects with acquired ptosis (203 treated for 6 weeks, 157 treated for 12 weeks), oxymetazoline significantly improved superior visual fields vs placebo, as measured by the Leicester Peripheral Field Test on hour 6, day 1, with a value of 6.3 for oxymetazoline vs 2.1 for vehicle (P < .0001) and with similar efficacy on hour 2, day 14, at 7.7 for oxymetazoline vs 2.4 for vehicle (P < .0001). It also improved outcomes on the Marginal Reflex Distance Test, which measures the distance from the center of the pupillary light reflex to the upper eyelid margin. Oxymetazoline was well tolerated over 6- and 12-week periods in safety trials; adverse reactions occurred in 1% to 5% of subjects, including punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation, and headache.

Hemoblast for Hemostasis

The Hemoblast Bellows (Biom’Up) is a handheld hemostasis device, where the surgeon squeezes the bellows to release sterile porcine collagen powder with glucose, chondroitin sulfate, and thrombin to achieve hemostasis during surgical procedures. The collagen powder absorbs ambient blood to facilitate coagulation; thrombin facilitates conversion of fibrinogen to fibrin; and chondroitin sulfate powder provides cohesion between the hemostatic wound and the surrounding tissue. The hemostatic agent combines tamponade and acceleration of fibrin clot formation as an adjunct to hemostasis when conventional procedures are impractical. To avoid risk of allergic-anaphylactic reaction and/or thromboembolic events, the product should not be introduced directly into vessels. A randomized study in 242 patients across 16 sites evaluated the safety and efficacy of Hemoblast Bellows against absorbable gelatin sponge and thrombin. The data showed enhanced coagulation with the device, including 71.1% vs 45.8% cessation of bleeding at 3 minutes (P = .001) and 93.1% vs 73.5% at 6 minutes (P = .001). There were no clinical signs or symptoms of postoperative bleeding with Hemoblast Bellows. This product has found use in cardiac and abdominal surgery; it may find use in large head and neck procedures.

StarPore for Aesthetic Rigid Implantation

StarPore implants (Anatomics, Pty, Ltd) include a series of anatomically contoured high-density polyethylene surgical implants designed for cartilage or bony reconstruction. They are made of star-shaped particles that form an interconnecting porous architecture analogous to the stellate character of trabecular bone, allowing for rapid infiltration of vascular tissue that may facilitate implant anchoring to tissues adjacent to the implant. The StarPore implant is strong and malleable, not susceptible to cracking or fracturing, and can be fixated with screws. Patient-specific implants based on available imaging are available. Any permanent implant is susceptible to complications of infection, extrusion, displacement, or adjacent bony resorption. Similar, precedent devices are generally well tolerated.

Rhinology

Novapak for Nasal Hemostasis

Novapak (Medtronic Xomed, PLC) was approved as a nasal packing and stent for use following sinus surgery or in the treatment of epistaxis. It is made of formulated chitosan and cellulose. The product prevents adhesions, controls mild bleeding, and may have antibacterial properties. The material, which can be cut to size and compressed for insertion, hydrates with sterile saline forming a gel. The sponge dissolves within the nasal cavity over 7 to 14 days with daily irrigation and natural mucus flow. Alternately, the dressing may be removed through gentle aspiration during postoperative debridement. Novapak is similar to NasoPore (fragmentable poly [DL-Lactide-co-e-caprolactone] urethane; Stryker ENT), but Novapak, according to studies supplied with its regulatory submission, has the potential additional benefit of providing a protective barrier to deter bacterial growth for up to 72 hours. In a meta-analysis published in 2017, Zhou et al found that, when compared with controls, a chitosan dressing similar to the material used in Novapak could significantly decrease edema and improve hemostasis, but it had no effect on granulations, mucosal edema, crusting, and infection. Novapak contains chitosan from shellfish and is contraindicated in patients with known shellfish allergies.

DrilCut-X for Endonasal Drilling

Karl Storz Endoscopy-America, Inc received clearance for the DrillCut-X II-35 Handpiece With 35k Sinus Burrs. This newly designed handpiece works with the Unidrive S III motor control unit, and various drill burr and sinus attachments are available. An optional handle is available to improve control and ergonomic feel ( ). The device incorporates suction and irrigation capabilities and can be adapted for use with various existing image-guided surgical systems from Karl Storz. The device is optimized for drilling and shaver functions in the sinonasal area at high speed—up to 35,000 rotations per minute (RPM) for drill burrs and 10,000 RPM for shaver blades. A significant increase from prior drills and shavers commonly used in rhinology, this level of RPM offers the potential for improved control, precision, and safety.

Figure 3.

DrillCut-X II-35 Handpiece With 35k Sinus Burrs for sinus surgery.

High-speed drilling has become recognized as a high-risk aerosol-generating procedure in the COVID-19 era. Recent work suggests that the presence of incorporated suction during drilling, in contrast to traditional drills, may reduce detectable droplet contamination outside the nasal cavity. This device reflects progressive innovation over decades with significant improvements in drilling and shaving capabilities. Such instrumentation is now indispensable in the safe and effective surgical treatment of chronic sinusitis and other sinonasal pathologies.

Updates to the TruDi System for Image-Guided Surgery

TruDi is the newest image-guided surgery (IGS) system by Johnson & Johnson Medical Devices (Acclarent) and updates its previous electromagnetic (EM) navigation system. The system can now import magnetic resonance scans and has a new TruMerge feature, allowing automatic merging of computed tomography and magnetic resonance scans. This is particularly helpful for endoscopic skull base surgery. The new version can connect to the facility’s PACS server (picture archiving and communication system) and can easily load scans directly from the network via TruPACS.

There is a new single-use TruDi probe that is compatible with the new TruDi navigation system, allowing intraoperative tracking. There are 2 probe configurations: straight (0°) and frontal (70°). Each probe comes with a disposable bending tool to adjust the configuration of the malleable tip. The advantages of this new tool include the ergonomic handle, low-profile design that improves maneuverability in tight anatomy, and malleable tip. A new malleable TruDi Curette is available and compatible with the system. This curette has an advantage over traditional sinus curettes because its distal tip sensor can be tracked during IGS. It comes with a disposable bending tool, which allows the surgeon to customize the shape of the distal shaft. It can bend anywhere from 0° to 90° to dissect and remove bone from the sinuses and skull base. It has gripping features on the shaft that assist with tactile feel.

Updates to the Stryker ENT Navigation System for IGS

The rapid increase in office-based sinus procedures over the past decade has created a demand for office-based navigation systems. Most manufacturers of operating room–based EM navigation systems offer versions that may be used in clinic. The Stryker ENT Navigation System offers a new universal headrest with mounting arm for its TGS image guidance ( ). This reusable device contains a headrest and chair adapter compatible with most ENT office chairs and a mounting arm that attaches to the headrest. The mounting arm provides fixation for the field generator of the navigation system and allows it to be positioned proximal to the patient’s head. This modification to its traditional field generator mounting arm provides convenience for consistent placement.

Figure 4.

Stryker ENT TGS Universal Headrest With Mounting Arm for in-office image guided navigation.

Stryker ENT has also developed the TGS Guidewire, which provides image guidance for the EM Navigation System and the XprESS LoProfile ENT Dilation System. The catheter is easily threaded through the balloon dilation system, aids localization of anatomic structures, and may prevent cerebrospinal fluid leak or scarring from incorrect placement. This device is similar to the TruDi Navwire (Johnson & Johnson Medical Devices), which was FDA approved in 2019. The main difference between the 2 EM guidewires are the intended balloon dilation systems and compatibility with navigation systems. Guidewires and IGS for balloon sinuplasty for frontal and sphenoid sinuses may become standard of care, mimicking traditional endoscopic sinus surgery.

ClearPath Nasal Balloon Catheter for Inferior Turbinate Displacement

The ClearPath Nasal Balloon Catheter (Intuit Medical Products) is a single-use balloon catheter that displaces the inferior turbinate and lower nasal septum to increase intranasal space. This product competes with the Relieva Tract Nasal Dilation System (Johnson & Johnson Medical Devices), offering a shorter length (25 vs 40 cm). The working end of the ClearPath device has a guide “spatula” on one side and the balloon on the other ( ). This allows the surgeon to selectively address nasal anatomy. The balloon applies force to the structure intended to be mobilized (eg, inferior turbinate), while distributing the opposing force to a larger area and protecting it from injury. Future studies on nasal septal balloon systems are needed to evaluate long-term outcomes on intranasal space and clinical relief of nasal obstruction.

Figure 5.

ClearPath nasal dilation system. The working end has a balloon on one side and a spatula on the other, preventing injury to the side away from the balloon.

Pediatrics

Expanded Indications for Hummingbird TTS (Tympanostomy Tube System) for In-Office Tympanostomy Tube Placement

The Hummingbird tympanostomy tube system (Preceptis Medical) is an in-office tympanostomy tube placement device for children 6 to 24 months of age. It was previously approved for use in conscious sedation, and it is now approved for awake, restrained patients. The expanded indications allow it to continue to compete with the Tula System (Tusker Medical), which was approved for similar indications last year. The Hummingbird device combines the separate steps of making a myringotomy, positioning the pressure equalization tube, and placing the tube with alligator forceps or picks. It has a 1-pass system: an incision is made with the cutting sheath, and the tube is placed by scrolling back on the slider. Insertion requires topical anesthetic. According to the FDA application data, tube insertion was completed with a median time of 5 minutes, and 99% of children successfully received ear tubes in the office; 85% of the time, it was successful with the first pass.

Expanded Indications for BiZact Tonsillectomy Device

The BiZact (Covidien, LLC) is a tonsillectomy device that has an ergonomic handle, a 12-cm shaft, and a curved jaw with bipolar electrocautery. It was previously approved for patients ≥12 years old, and it now has an indication for patients ≥3 years old. The ergonomic design allows use with both hands and is designed to follow the shape of the tonsil bed. The curved jaw allows for dissection and sealing while dividing tissue, possibly improving operative time. In a study by Krishnan et al, the average surgical time with the device was 5.1 minutes for all age groups, and the postoperative bleed rate was 4.3%.

General

Otoset Ear Cleaning System for Ear Wax Removal

Otoset (Safkan Health) is the first automated FDA-approved ear cleaning device for clinical use. It is approved for adults. It combines liquid flow and a microsuction to break down and remove impacted cerumen. The Otoset system includes a headphone-like apparatus with a fluid reservoir, suction, and disposable ear tips ( ). The device uses a 35-second cleaning cycle where liquid flow is directed from solution containers through disposable ear tips and toward the walls of the ear canals to break down cerumen. Continuous microsuction draws the earwax and liquid back through the ear tips and into disposable waste containers to limit water spills during the earwax removal procedure. Primary care clinics, where a microscope for cerumen removal may not be readily available, are likely the target market.

Figure 6.

Otoset cerumen removal device.

Rimegepant and Eptinezumab for Migraine

Although most otolaryngologists do not routinely treat migraine, they have a role in managing or referring vestibular migraine, atypical facial pain, and other migrainous disabilities. Treatment for migraine is evolving rapidly, and 2 medical therapies were newly approved. Notably, these therapeutics are promising for migraine headache, but there is a paucity of data on treatment of atypical facial pain or vestibular migraine.

Rimegepant (Nurtec ODT; Biohaven Pharmaceuticals, Inc) is a calcitonin gene-related peptide receptor agonist approved for the treatment of acute migraine, dosed as an oral dissolvable tablet. In a double-blind randomized controlled trial by Croop et al, migraine was resolved in 21% of patients as opposed to 11% in placebo at 2 hours after therapy. Although approved for acute migraine, recent work suggests that it may be effective for migraine prevention; this is a unique finding for migraine therapies. Adverse reactions are typically nausea and nasopharyngitis, which occur at nearly the same rate as placebo.

Eptinezumab (Vyepti; Lundbeck Seattle BioPharmaceuticals, Inc) was approved for migraine prevention. It targets the calcitonin gene-related peptide receptor, though with an anticlonal antibody requiring intravenous administration. In a randomized controlled trial by Lipton and colleagues, patients experienced about 2 fewer migraine episodes a month than placebo. Nasopharyngitis, fatigue, and nausea were slightly more common than placebo.

Limitations

The FDA is a conservative body, and the drugs and devices approved may be years behind the innovations reported in the academic literature or the technologies available to the market outside the United States. However, some approved technologies have limited scientific data available to assess their role in practice or long-term outcomes. This limitation is acutely evident with teprotumumab for thyroid eye disease, where a case of cognitive decline was identified only in postmarket surveillance. Furthermore, there is subjectivity inherent in determining which drugs and devices were clinically relevant to the specialty, and discussion of incremental advances was limited by prioritization. Finally, despite our effort to be exhaustive, otolaryngology is a very broad field, and some impactful technologies may have been identified outside our queries.

Implications for Practice

Innovations available to the otolaryngologist change rapidly. Novel technologies have variable impact on care, with some new products losing relevance with time while others become paradigm shifting and establish new standards of care. Staying at the forefront of medical advances benefits our patients to ensure that they receive the highest-quality, safest care available.

Author Contributions

Michael J. Brenner, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Jared A. Shenson, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Austin S. Rose, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Tulio A. Valdez, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Masayoshi Takashima, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Omar G. Ahmed, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Philip A. Weissbrod, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Robert S. Hong, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Hamid Djalilian, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Jeffrey S. Wolf, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Robert J. Morrison, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Peter L. Santa Maria, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity; Isaac D. Erbele, contributed to the study design, data acquisition, and analysis; approved the final manuscript; and agrees to be accountable for its veracity

Disclosures

Competing interests: Peter L. Santa Maria: Auration Biotech, Flotherm, Stryker. Robert S. Hong: Olympus. Hamid Djalilian: Beyond Tinnitus, Cactus Medical, Elinava Technologies. Austin S. Rose: Tivic Health Systems. Some FDA approvals were awarded to manufacturers that provide financial support to this journal’s sponsoring society, the American Academy of Otolaryngology–Head and Neck Surgery Foundation. A listing of foundation donors is available at https://www.entnet.org/about-us/aao-hns-foundation/our-donors/.

Sponsorships: None.

Funding source: None.