Sophie J. Balk, MD, from the Children’s Hospital at Montefiore and Albert Einstein College of Medicine in Bronx, New York, and colleagues reviewed the effects of noise and specific pediatric exposure to noise and then developed recommendations for preventing excessive noise exposure.

The authors note that pediatricians should incorporate information about noise and preventing excessive exposure into health supervision practices. The most prevalent exposure is likely to be from personal listening devices; excessive and/or prolonged exposure to high volumes can result in hearing loss, tinnitus, and/or hyperacusis. A child should be able to hear when spoken to and should take breaks from the device. The duration of exposure to noise (dose of noise) and not just the volume is significant; as one increases, the other should decrease. In addition, consideration of the frequency of exposure is needed. Advice to caregivers includes avoiding or leaving excessively noisy venues or using hearing protection, even on young infants. Whenever possible, children should be shielded from impulse noise. When impulse noise is expected, double hearing protection can reduce the risk for hearing loss.

“Now is the time to raise public awareness about noise levels and their impact on our health and the health of our children and teens,” Balk said in a statement. “While loud noises are often accepted or even celebrated during recreational events, there are ways we can protect ourselves. Let’s lower the volume on our devices — and raise our voices on protecting our ears.”

Policy Statement

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Acute Otitis Media Treatments

Nader Shaikh, MD, from the University of Pittsburgh School of Medicine, and colleagues developed and internally validated an artificial intelligence decision-support tool to interpret videos of the tympanic membrane and enhance accuracy in the diagnosis of AOM. Otoscopic videos of the tympanic membrane captured using a smartphone during outpatient clinic visits at 2 sites in Pennsylvania were analyzed; 1151 videos from 635 children (most younger than 3 years) were included in the study.

The researchers found that diagnostic accuracy was almost identical for the deep residual-recurrent neural network and the decision tree network. Tympanic membrane videos were classified into AOM versus no AOM categories with a sensitivity and specificity of 93.8 and 93.5%, respectively, with the finalized deep residual-recurrent neural network, while the decision tree model had corresponding sensitivity and specificity of 93.7 and 93.3%. Bulging of the tympanic membrane aligned with the predicted diagnosis most closely; in the test set, bulging was present in all 230 cases in which the diagnosis was predicted to be AOM.

“With appropriate training, this tool could be used by a wide range of medical personnel to enhance teaching of otoscopic examination, discussion with colleagues, documentation in the electronic health record, and discussion with parents,” the authors write.

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HealthDay News — ChatGPT provides helpful postoperative instructions for families of pediatric otolaryngology patients with low health literacy, according to a research letter published online April 27 in JAMA Otolaryngology-Head & Neck Surgery.

Noel F. Ayoub, MD, from the Stanford University School of Medicine in California, and colleagues assessed the value of ChatGPT (vs Google Search and a university) in augmenting patient knowledge and generating postoperative instructions for use in populations with low educational or health literacy levels. The analysis included postoperative patient instructions for eight common pediatric otolaryngologic procedures.

The researchers found that understandability scores, overall, ranged from 73 to 91%; actionability scores ranged from 20 to 100%; and procedure-specific items ranged from 0 to 100%. ChatGPT-generated instructions (requested for a fifth-grade reading level) were scored from 73 to 82% for understandability, 20 to 80% for actionability, and 75 to 100% for procedure-specific items. Institution-generated instructions had the highest understandability scores (91% vs 81% for both ChatGPT and Google Search) and actionability scores (92% vs 73% for ChatGPT and 83% for Google Search). For procedure-specific items, scores were highest for institution-generated and ChatGPT instructions (both 97% vs 72% for Google Search).

“Despite these findings, ChatGPT may be beneficial for patients and clinicians, especially when alternative resources are limited,” the authors write.

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HealthDay News — The cumulative incidence of cisplatin-induced hearing loss (CIHL) is higher in young children, according to a study published online September 7 in Cancer.

Annelot J.M. Meijer, from the Princess Maxima Center for Pediatric Oncology in Utrecht, Netherlands, and colleagues retrospectively reviewed data from Canadian patients with childhood cancer. The cumulative incidence of CIHL was estimated for the total cohort and according to age. The effects of independent variables on CIHL development up to three years after the start of therapy were explored.

Data were included for 368 patients with 2052 audiological assessments. The researchers found that at 3 years after initiating therapy, the cumulative incidence of CIHL was highest in patients aged 5 years and younger (75%) compared with 48% for patients older than 5 years. The cumulative incidence of CIHL increased rapidly from the start of cisplatin treatment, to 27 and 61% at 3 months and 1 year, respectively, among children aged 5 years and younger. Over time, factors that further influenced CIHL development included total cumulative dose of cisplatin at 3 months (hazard ratio, 1.20 per 100mg/m² increase), vincristine (hazard ratio, 2.87), and the total duration of concomitantly administered antibiotics (hazard ratio, 1.85 for more than 30 days).

“The cumulative incidence of CIHL is higher in younger children and develops at an earlier stage during therapy compared with older children,” the authors write. “These results highlight the need for close audiological monitoring at each cisplatin cycle, especially in very young children.”

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The Food and Drug Administration (FDA) has approved SYNCHRONY and SYNCHRONY 2 (MED-EL) cochlear implant systems for single-sided deafness and asymmetric hearing loss.

Specifically, the devices are now indicated for patients aged 5 years and older with single-sided deafness who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear, or patients aged 5 years and older with asymmetric hearing loss who have profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB in pure tone averages between ears.

The approval was based on data from a study involving 40 patients aged 18 and older who had single-sided sensorineural profound hearing loss in one ear, or asymmetric hearing loss, for less than 10 years and had used a hearing aid regularly for at least some of that time. 

Results showed that both groups had improvements in their ability to understand speech in quiet, listen to speech in noise, and find the direction of a sound source after one year of implant use.

To be implanted with either system, individuals must obtain limited benefit from an appropriately fitted unilateral hearing aid. 

For more information visit medel.com.

HealthDay News — Children from socially disadvantaged backgrounds are less likely to receive treatment for otitis media and more likely to experience complications from undertreatment, according to a study published online Nov. 10 in JAMA Otolaryngology-Head & Neck Surgery.

To quantify social disparities in treatment patterns, Z. Jason Qian, MD, and David H. Rehkopf, ScD, MPH, both from the Stanford University School of Medicine in California, used insurance claims data from the Optum Clinformatics Data Mart Database (between January 1, 2003, and March 31, 2021) with linked inpatient, outpatient, and pharmaceutical claims for 4.8 million US children with otitis media.

The researchers found that among the 4.8 million children, 20.59% were treated for recurrent otitis media, 14.86% were treated for suppurative otitis media, 6.95% received tympanostomy tubes, and 0.23% were treated for severe complications. Earlier age at diagnosis, male sex, environmental allergies, gastroesophageal reflux, and adenotonsillar hyperplasia were all associated with increased treatment for otitis media, when adjusting for patient factors and social indices. In contrast, social deprivation was associated with lower odds of medical treatment for recurrent otitis media (odds ratio, 0.86), suppurative otitis media (odds ratio, 0.61), and insertion of tympanostomy tubes (odds ratio, 0.76), as well as higher odds of treatment for severe complications of undertreated otitis media (odds ratio, 1.28).

“As otitis media is a modifiable risk factor for hearing loss, efforts need to be made to ensure equitable access to treatment for all children,” the authors write.

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A recently published report describes the case of a 13-year-old female patient who experienced precipitate formation in her ear canal following a course of topical ciprofloxacin/dexamethasone for treatment of otitis externa and discusses the potential of this side effect as well its management.

The patient, who was healthy with no significant past medical history, first presented to her pediatrician complaining of significant ear discomfort. Upon examination, the patient’s external ear canal was found to be inflamed, red, and swollen, and she was subsequently diagnosed with otitis externa. 

The patient was instructed to instill 4 drops of topical ciprofloxacin/dexamethasone 0.3%-0.1% otic suspension into the affected ear twice daily for a total of 7 days. Additionally, the patient’s mother was counseled by the pharmacist to shake the medication bottle prior to each use.

Although the patient’s pain and discomfort resolved after completion of her treatment, she immediately began experiencing loss of hearing, itchiness, and the feeling of something present in her ear. At her second visit to the pediatrician concerning these symptoms, examination of the patient’s ear revealed a “white sandy substance” covering her eardrum. 

An elephant ear washer system was used to remove a large amount of the white particles, however, additional particles were found to be present on the patient’s tympanic membrane. The pediatrician rinsed the patient’s ear again and referred her to an ear nose and throat (ENT) doctor. 

At her ENT appointment the following day, the physician removed the “offending agent” with surgical tweezers. The case report noted, “Visual examination revealed a cast of the tympanic membrane due to precipitate (measuring approximately 1.2cm in length) being stuck to the cerumen inside the patient’s ear.” Liquid chromatography with tandem mass spectrometry was utilized and confirmed that the substance was a result of ciprofloxacin/dexamethasone precipitation. After removal of the precipitate, the patient’s symptoms resolved and her hearing returned.

“We hypothesize that ciprofloxacin may chelate with multivalent cations found in cerumen, causing the precipitate to adhere to the cerumen, resulting in a cast on the patient’s eardrum,” the authors stated. They added that “Patients being treated with this medication should be warned of this possibility.”

Reference

Curtis SD, Egelund EF, Ebied AM. Ciprofloxacin/dexamethasone precipitate formation in the ear canal of a paediatric patient [published online July 2020]. BMJ Case Reports. doi: 10.1136/bcr-2020-234290.

The Food and Drug Administration (FDA) has approved Eylea^® (aflibercept) for the treatment of preterm infants with retinopathy of prematurity (ROP).

Eylea is a vascular endothelial growth factor (VEGF) inhibitor. The approval was based on data from the phase 3 BUTTERFLEYE (ClinicalTrials.gov Identifier: NCT04101721) and FIREFLEYE (ClinicalTrials.gov Identifier: NCT04004208) trials. Study participants had a maximum gestational age at birth of 32 weeks or a maximum birth weight of 1500g, had to weigh at least 800g on the day of treatment and had treatment-naïve ROP.

Patients were randomly assigned to receive 0.4mg of aflibercept via intravitreal injection or laser photocoagulation (the standard treatment for ROP). The primary endpoint was the proportion of patients with absence of active ROP and unfavorable structural outcomes at week 52 of chronological age. 

Findings from both trials showed that nearly 80% of patients who received aflibercept achieved an absence of active ROP and unfavorable structural outcomes at 52 weeks of age. Neither trial achieved superiority or inferiority of one arm compared with the other arm. In both trials, more than 92% of all patients who were treated with aflibercept received bilateral injections.

“Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also the family navigating a delicate time after a preterm birth,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, and a principal inventor of Eylea. “For the first time, physicians will now have an FDA approved medication in Eylea to treat this heartbreaking disease in these smallest of patients.”

Following administration of Eylea, there is a risk of reactivation of abnormal angiogenesis and tortuosity. Infants should be monitored closely after injection until retinal vascularization has completed or until the examiner is assured that reactivation of ROP will not occur.

Eylea is also indicated for the treatment of adults with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

References

1. Eylea^® (aflibercept) Injection approved as the first pharmacologic treatment for preterm infants with retinopathy of prematurity (ROP) by the FDA. News release. Regeneron Pharmaceuticals, Inc. February 8, 2023. Accessed February 9, 2023. https://www.globenewswire.com/news-release/2023/02/08/2604539/0/en/EYLEA-aflibercept-Injection-Approved-as-the-First-Pharmacologic-Treatment-for-Preterm-Infants-with-Retinopathy-of-Prematurity-ROP-by-the-FDA.html.
2. Eylea. Package insert. Regeneron Pharmaceuticals, Inc.; 2023. Accessed February 9, 2023. https://www.regeneron.com/downloads/eylea_fpi.pdf.

The Food and Drug Administration (FDA) has approved the Tubes Under Local Anesthesia (Tula) System (Tusker Medical) for the treatment of recurrent otitis media in patients ≥6 months of age. 

The Tula system is the first tympanostomy tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. The system uses a small electrical current to deliver the local anesthetic Tymbion into the eardrum prior to tube insertion.

The approval was based on data from 222 pediatric patients who received ear tubes through the Tula system. The procedural success rate was 86% in children under 5 years and 89% in those aged 5 to 12 years. The most common adverse reaction observed in the trial was inadequate anesthesia during the procedure. The procedure is not intended for patients who may have pre-existing eardrum issues (ie, perforated eardrum).

“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort.”

For more information visit tuskermed.com.

The Food and Drug Administration (FDA) has granted 510(k) clearance to OtoSet^TM – Ear Cleaning System (SafKan Health) to remove impacted earwax.

OtoSet is an automated ear cleaning device that resembles a set of headphones. The device breaks down earwax by using irrigation directed from solution containers through disposable ear tips and toward the walls of the ear canals. Continuous microsuction then draws the liquid and earwax back through the ear tips and into disposable waste containers.

The device provides at least 50 earwax removal procedures per battery charge. Both bilateral and unilateral procedures can be performed with a total procedure time of under 5 minutes. OtoSet is expected to be available in late 2020.

“As an educator of primary care physicians, I can envision physicians of the future using OtoSet as an essential tool in patient care,” said Dr Gary Kato, a primary care physician affiliated with the University of Washington Medicine.

A consumer version of OtoSet is also in the works, according to Sahil Diwan, co-founder and CEO of SafKan Health.

For more information visit safkanhealth.com.

References

1. New FDA cleared automated ear cleaning device brings ear care into the 21st century. [press release]. Seattle, WA: SafKan Health; November 12, 2020. 
2. SafKan Health website. https://www.safkanhealth.com/otoset.html. Accessed November 12, 2020.

The Food and Drug Administration has granted 510(k) clearance to TOMi Scope (PhotoniCare) as an imaging tool for visualization of the human tympanic membrane and middle ear space.

The TOMi Scope uses video otoscopy and optical coherence tomography to directly visualize the contents of the middle ear providing a high-resolution depth image on-screen. The device provides cross-sectional images of the middle ear as well as a high resolution video of the eardrum surface. Clinicians are able to directly visualize fluid in the middle ear and measure the fluid’s density, even in the presence of wax. These images may also be saved for later analysis.

The Company expects to immediately launch the TOMi Scope in a limited release in select US geographies, with a full national launch later in 2020.

“Current tools can only provide a view of the surface of the eardrum, forcing physicians to make an assessment with very limited information, or to employ invasive surgical procedures to accurately identify middle ear pathologies,” said Diego Preciado, MD, PhD of the Children’s National Hospital in Washington, DC, a lead investigator for clinical studies of the device. “TOMi Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments.”

For more information visit photoni.care.

The US Food and Drug Administration (FDA) approved a wide range of therapies in 2023, including many new molecular entities and biological products. The information below is organized by the month in which the product received approval. 

HealthDay News — Affordable over-the-counter hearing aids could soon bring relief to millions of Americans suffering from hearing loss, under a landmark proposal announced Tuesday by the US Food and Drug Administration.

The proposal would create a category of hearing aids that could be sold directly to consumers, without either a medical exam or a fitting by an audiologist. Until now, patients suffering from hearing loss have typically had to pay thousands of dollars for a device that could only be adjusted by a professional audiologist.

That has been a barrier that left many without the hearing help they need. While roughly 15% of Americans report some trouble with their hearing, the FDA estimates that only one in five people who could benefit from a hearing aid actually use one.

The proposal is the culmination of efforts dating back to 2017, when Congress passed a law requiring the FDA to establish a category of over-the-counter hearing aids. The FDA missed its August 2020 deadline to propose those new rules, blaming the COVID-19 pandemic for the delay. But in July, President Joe Biden issued an executive order that set a November deadline for the FDA to finish its work on the new hearing aid rule.

The over-the-counter hearing aids produced under the proposed rule would be intended for adults with mild-to-moderate hearing loss, the FDA said. Hearing aids for severe hearing loss or for children younger than 18 years would still require a prescription and a professional fitting.

To ensure patient safety, the proposal also sets a maximum volume limit for over-the-counter hearing aids, which is intended to prevent injuries from overamplification. The proposal also includes performance and design requirements for the devices, including limits on distortion control, self-generated noise, processing speed, range of reproducible frequencies, and insertion depth of the device. Lastly, the proposal also would set labeling requirements for over-the-counter hearing aids.

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The Food and Drug Administration (FDA) has granted Fast Track designation to FX-322 (Frequency Therapeutics) for the treatment of sensorineural hearing loss.

FX-322 is a combination of proprietary small molecules designed to regenerate damaged auditory cells by activating progenitor cells in the inner ear. The investigational treatment is administered intratympanically into the middle ear during an office-based procedure that the Company states takes approximately 10 to 15 minutes.

The designation is based on results from a 3-month, phase 1/2 trial that assessed the safety of FX-322 in adults with stable sensorineural hearing loss (N=23). Patients were randomized to receive either a high-dose or low-dose of FX-322 administered as a single intratympanic injection or placebo in one ear. Results showed FX-322 was safe and well-tolerated with no serious adverse events reported. Additionally, the treatment was associated with statistically and clinically meaningful improvements in hearing function, including clarity of sound and word recognition.

The Company is currently conducting a phase 2a trial to evaluate the efficacy of intratympanic FX-322 that will assess the effectiveness of the treatment on word recognition, words-in-noise, and standard pure tone audiometry. Full study data is expected in the second half of 2020.

“Starting our phase 2a study shows continued momentum as we further our understanding of the potential of FX-322, both in measures of loudness and clarity, and work to develop a disease modifying treatment for the millions of people living with sensorineural hearing loss,” said David Lucchino, CEO of Frequency Therapeutics. “We are also pleased that the FDA has granted Fast Track designation for FX-322 and we look forward to continuing our ongoing work with the agency as our study progresses.”

For more information visit frequencytx.com.

The Food and Drug Administration (FDA) has issued a final rule establishing a new category of over-the-counter (OTC) hearing aids, allowing individuals 18 years of age and older with mild to moderate hearing impairment to purchase hearing aids without a prescription.

The final rule is expected to lower the cost of hearing aids while ensuring their safety and efficacy. It comes after President Biden’s Executive Order on Promoting Competition in the American Economy, which called for the Secretary of Health and Human Services to “promote the wide availability of low-cost hearing aids.” In 2017, Congress passed legislation requiring the FDA to create a category for OTC hearing aids, but it was not fully implemented until now.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October without the need for a medical exam, prescription or a fitting adjustment by an audiologist. Manufacturers of hearing aids sold prior to the effective date of the final rule will have 240 days after its publication to comply.

The new OTC category applies to certain air-conduction hearing aids intended for individuals 18 years of age and older who have perceived mild to moderate hearing impairment. Moreover, the final rule lowers the maximum sound output to reduce the risk to hearing from over-amplification of sound, revises the insertion depth limit in the ear canal, requires that all OTC hearing aids have a user-adjustable volume control, and includes performance specifications and device design requirements specific to OTC hearing aids.

Reference

FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans. News release. US Food and Drug Administration (FDA). Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-american

The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) to Fennec Pharmaceuticals regarding the New Drug Application (NDA) for Pedmark (sodium thiosulfate) for the prevention of ototoxicity associated with cisplatin chemotherapy in patients 1 month to less than 18 years of age with localized, nonmetastatic solid tumors.

The NDA for Pedmark was resubmitted in May 2021, after the FDA issued a CRL in August 2020 citing deficiencies during a pre-approval inspection of the manufacturing facility. In the most recent CRL, the FDA again noted that the application could not be approved in its present form due to manufacturing deficiencies. The Company is requesting a Type A meeting to discuss the issues mentioned in the letter.

The application includes data from 2 pivotal phase 3 trials, SIOPEL 6 (ClinicalTrials.gov Identifier: NCT00652132) and ACCL0431 (ClinicalTrials.gov Identifier: NCT00716976), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss. Findings from both trials showed that the likelihood of hearing loss was significantly lower in the sodium thiosulfate treatment arm compared with cisplatin alone.

“We are steadfast in our commitment to reducing the risk of life-long hearing loss for children and young adults receiving cisplatin chemotherapy who currently have no approved therapies for this devastating condition,” said Rosty Raykov, CEO of Fennec Pharmaceuticals. “We will work closely with our current manufacturer as well as the FDA to fully address the issues raised in the letter.”

The FDA previously granted Breakthrough Therapy and Fast Track designations to Pedmark for this indication.

Reference

Fennec Pharmaceuticals receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to prevent ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic, solid tumors. News release. Fennec Pharmaceuticals Inc. Accessed November 30, 2021. https://www.globenewswire.com/news-release/2021/11/30/2342800/0/en/Fennec-Pharmaceuticals-Receives-Complete-Response-Letter-from-the-FDA-for-its-New-Drug-Application-for-PEDMARK-to-Prevent-Ototoxicity-Associated-with-Cisplatin-in-Pediatric-Patient.html.