Tepezza (teprotumumab) was approved in 2020 as the first and only FDA-approved therapy for thyroid eye disease (TED). While the drug has shown promising results in reducing inflammation and bulging of the eyes, concerns have emerged about an unexpected and potentially serious side effect: hearing loss.
Since its release, patients have reported auditory symptoms ranging from tinnitus and ear fullness to sensorineural hearing loss. These reports are not anecdotal outliers. Controlled trials, peer-reviewed medical studies, post-market surveillance data, and FDA safety updates all point to a consistent signal.
For individuals who began experiencing hearing-related problems after using Tepezza, there may be cause to explore whether the drug contributed to these complications—and what legal rights they may have as a result.
This article reviews the current medical and scientific evidence linking Tepezza (teprotumumab) to hearing loss. Evidence behind Tepezza’s connection to hearing impairment and explains how that evidence may apply to those considering legal action.
Reach out to Lawsuit Legal News for a free consultation with our dedicated legal team who can answer your questions about whether you qualify to bring a Tepezza hearing loss lawsuit.
Don't wait any longer, call 866-535-9515 or submit your case for review today!
Early Warnings from Clinical Trials
Hearing-related concerns first appeared during Tepezza's clinical testing. In a pivotal Phase 2 trial published in The New England Journal of Medicine (2017), three out of 42 patients treated with teprotumumab reported auditory symptoms. These included one case of tinnitus, one mild bilateral hearing loss that resolved, and a more concerning case of delayed-onset hearing loss that began 16 weeks after therapy concluded.
These incidents represented approximately 7% of the treatment group compared to zero cases in the placebo group. While the numbers were small, they prompted closer scrutiny during the Phase 3 trial, which involved a larger group of thyroid eye disease patients.
In that subsequent trial, published in 2020, approximately 10% of patients receiving Tepezza reported hearing-related adverse events. Symptoms included tinnitus, hypoacusis (diminished hearing), hyperacusis (sound sensitivity), autophony (hearing one’s own voice loudly), and eustachian tube dysfunction. None of these events occurred in the placebo arm of the trial.
Although most cases were classified as mild and transient, one patient experienced hearing loss described as deafness. These early trials established that auditory side effects could occur—and may not always resolve on their own.
Real-World Studies Show Higher Incidence
While the 10% rate observed in clinical trials was concerning, more recent studies conducted in real-world clinical settings have shown higher incidence rates of hearing problems, mainly when formal audiology testing is used.
Sears et al. (2022) conducted a prospective observational study at Stanford University. Among 27 patients receiving Tepezza, 22 (81.5%) reported new auditory symptoms. These ranged from mild sensations like ear popping to significant difficulty hearing speech. Only six patients received baseline and follow-up audiograms, but five (83%) were confirmed to have new sensorineural hearing loss (SNHL) on objective testing. The authors noted that their incidence rate far exceeded that observed in earlier trials and suggested that the discrepancy may be due to more detailed monitoring in clinical practice.
Belinsky et al. (2022) examined 28 patients treated with Tepezza across multiple centers. Four of those patients developed clinically significant hearing loss, which was confirmed through audiological evaluation. The authors concluded that Tepezza may cause a range of hearing problems—from mild, temporary symptoms to potentially irreversible loss—and recommended audiometric screening before and during treatment.
Douglas et al. (2024) followed 52 patients receiving Tepezza in a prospective cohort with standardized audiology testing at baseline and six months after treatment. Five patients (about 10%) had a measurable hearing decline. Significantly, those with prior hearing problems were disproportionately affected, suggesting that preexisting ear conditions or age-related vulnerability may increase the risk.
Keen et al. (2024) further supported these findings in a case series using strict ototoxicity criteria. Among 22 patients, 11 (50%) experienced a measurable decline in hearing thresholds—particularly at high frequencies. Older patients were significantly more likely to experience this decline, underscoring age as a consistent risk factor.
These studies reveal that auditory side effects are more common than initially estimated. Controlled trials may underreport ototoxicity due to limited monitoring. When tested with audiograms before and after therapy, many patients exhibit measurable hearing loss—even if they do not initially report symptoms.
FDA Label Updates and Hearing Loss Warnings
In response to accumulating data, the U.S. Food and Drug Administration updated the official prescribing information for Tepezza in July 2023. The new labeling added a prominent warning under the “Warnings and Precautions” section for “Hearing Impairment Including Hearing Loss.”
The label now states that Tepezza may cause hearing problems that sometimes do not resolve. It advises healthcare providers to assess patients’ hearing before, during, and after treatment. Physicians are also encouraged to consider the risks in patients with existing auditory conditions.
Hearing loss is now listed among the most commonly reported adverse reactions, alongside more well-known side effects like muscle spasms, alopecia, and hyperglycemia.
While the FDA did not issue a formal Dear Healthcare Provider letter, the label change has been disseminated in clinical journals and specialty communities, particularly among endocrinologists and ophthalmologists treating TED.
This action confirms that auditory side effects are no longer regarded as rare or anecdotal. The warning reflects regulators' recognition that the risk is credible, potentially significant, and worthy of proactive screening.
Post-Marketing Surveillance and FAERS Data
Beyond trials and case series, national safety databases also support a link between Tepezza and hearing impairment. The FDA Adverse Event Reporting System (FAERS) collects voluntary reports from patients, clinicians, and manufacturers.
A 2024 analysis by Huynh et al., published in Otology & Neurotology, reviewed FAERS reports submitted between Q1 2020 and Q1 2023. Of 2,109 reported adverse events associated with Tepezza, 296 cases (14.1%) involved ear-related complications.
Of those, 149 cases (7.1%) specifically reported hearing loss or auditory impairment. An additional 194 cases included tinnitus, vertigo, and ear fullness. Some patients experienced multiple overlapping symptoms.
Notably, the authors performed a disproportionality analysis comparing the rate of hearing-related events with Tepezza to the expected background rate. The result was a reported odds ratio (ROR) of approximately 44—suggesting that hearing-related complaints occur at a markedly higher rate with Tepezza than with most other drugs in the FAERS database.
The analysis also found that older patients were more likely to report hearing loss, with those aged 65 and above experiencing more than triple the odds of adverse auditory events compared to younger patients.
While FAERS data cannot establish causality independently, the signal is consistent with trial data and observational research. Together, they reinforce that Tepezza carries a meaningful risk of hearing impairment, particularly in older adults or those with preexisting ear issues.
Mechanism of Injury – Why Tepezza May Impact Hearing
Tepezza targets and inhibits the insulin-like growth factor-1 receptor (IGF-1R), which is involved in the inflammatory pathway responsible for thyroid eye disease. While this mechanism reduces inflammation behind the eyes, it may have unintended consequences elsewhere in the body—including the auditory system.
IGF-1 plays a well-established role in maintaining the health of cochlear hair cells and auditory neurons. Animal studies have shown that mice lacking IGF-1 develop early-onset hearing loss due to the degeneration of inner ear structures. Conditions marked by low IGF-1 levels—such as Laron syndrome—are associated with reduced hearing function in humans.
By blocking IGF-1R, Tepezza may disrupt this protective signaling in the inner ear, leading to the degeneration of hair cells responsible for transmitting sound. This is supported by clinical findings showing a predominance of high-frequency hearing loss among affected patients.
Researchers have also observed other symptoms suggestive of Eustachian tube dysfunction, including autophony and ear pressure. Because IGF-1R is present in multiple tissues, its inhibition may affect cochlear and middle ear function.
Some physicians have proposed experimental interventions to reverse or reduce hearing damage, such as intratympanic IGF-1 injections. However, such treatments remain unproven, and prevention through monitoring remains the primary strategy.
This mechanism provides a biologically plausible explanation for Tepezza-related hearing changes and supports causation in both medical and legal contexts.
Patient Case Reports Add Clinical Context
In addition to trials and cohort studies, published case reports offer detailed insights into how Tepezza may impact individual patients. These accounts often include audiograms, clinical timelines, and therapeutic decisions, helping illustrate the range and progression of symptoms.
One case published by Chow and Silkiss (2022) described a woman in her 50s who began experiencing tinnitus after her third infusion of Tepezza. By the fifth dose, she had developed a noticeable hearing decline. Audiometric testing revealed a 15–30 dB loss across several frequencies. Despite discontinuing treatment early, her hearing did not improve in follow-up testing six weeks later. The clinicians concluded that her sensorineural hearing loss was likely permanent.
Another report by Phansalkar et al. (2023) involved a 64-year-old patient who experienced significant auditory decline after four infusions. She discontinued therapy due to the severity of her symptoms. However, one year later, her thyroid eye disease worsened, prompting clinicians to reintroduce Tepezza at a reduced dose. With careful monitoring, she completed treatment without further hearing complications. This case showed that dose adjustments might mitigate ototoxic effects in selected patients.
Other published cases have documented sudden-onset hearing loss, delayed auditory symptoms after the infusion cycle ends, and situations where symptoms persisted for months. Some patients developed symptoms despite having no previous ear conditions, while others experienced worsening of preexisting hearing deficits.
Though individual experiences differ, these reports add weight to broader findings by showing how Tepezza’s auditory side effects can emerge, progress, and in some cases, persist. The case documentation also highlights the importance of routine audiometric monitoring and early symptom recognition.
How Scientific Evidence Supports Legal Claims
Evidence from scientific literature plays a foundational role in evaluating potential drug injury claims. Courts and legal teams assess whether a causal connection exists between the medication and the reported harm. In the case of Tepezza, multiple layers of objective evidence contribute to that evaluation.
Peer-reviewed clinical trials provide the first signal, showing a clear difference in hearing-related symptoms between treatment and placebo groups. Observational studies reinforce that risk, primarily when formal hearing evaluations are used. Case series and reports offer detailed accounts of patient experiences that align with the broader data trends.
Beyond clinical literature, the FDA’s decision to update the drug’s label in 2023 lends institutional weight to the association. Regulatory recognition that Tepezza can cause permanent hearing loss strengthens the plausibility of claims.
The drug’s known mechanism of action further supports scientific plausibility. Inhibiting IGF-1R interrupts a biological pathway essential to inner ear health. This mechanistic link is well-documented in medical literature and aligns with the pattern of hearing changes seen in affected patients.
For individuals seeking legal action, the most substantial claims often involve an audiometric confirmation of hearing loss, a clear treatment timeline, and the absence of alternative causes. The combination of published science, objective testing, and regulatory acknowledgment may provide a compelling basis for pursuing compensation related to Tepezza-induced hearing damage.
What to Do If You Experience Hearing Issues After Tepezza
You may wonder what steps to take if you develop hearing symptoms during or after Tepezza treatment. While not all auditory side effects result in permanent damage, early documentation is essential—especially if legal action is being considered.
First, request a comprehensive hearing exam from a licensed audiologist. Baseline audiograms performed before treatment can help establish causation if post-treatment changes are documented.
Second, report all hearing-related symptoms to your prescribing physician. Document the timing, duration, and severity of each symptom. If hearing issues began during or shortly after your infusion cycle, include those details in your medical records.
Third, consider speaking with a Tepezza injury lawyer with experience evaluating pharmaceutical injury claims. An initial review can help determine whether your case meets the criteria for legal pursuit.
Do I Need a Lawsuit Attorney?
You do not need to be sure you want to file a lawsuit to speak with an attorney. What matters is whether you experienced hearing symptoms during or after treatment—and whether those symptoms have had a lasting impact. Early legal guidance helps preserve documentation and assess whether a valid claim exists. It also ensures deadlines are not missed while you continue evaluating your options.
Although some individuals recover hearing function over time, others report persistent or worsening symptoms. If your hearing loss has not resolved, a case review may clarify whether Tepezza contributed and whether compensation may be appropriate.
Scientific evidence supporting the link between Tepezza and hearing loss has grown steadily. Clinical trials, patient case reports, FDA safety updates, and medical literature point to a consistent risk, particularly among older patients or those with preexisting hearing conditions.
If you experienced tinnitus, muffled hearing, or ear pressure during or after receiving Tepezza, it is worth discussing your situation with a legal team familiar with pharmaceutical injury claims. A case evaluation can help determine whether your medical records align with the evidence used in similar claims—without requiring any upfront commitment.
Speak With a Tepezza Hearing Loss Attorney About Your Legal Options
If you began experiencing hearing loss, tinnitus, or other auditory symptoms after Tepezza treatment, you may have grounds to pursue legal action. At Lawsuit Legal News, we review claims for individuals who believe their hearing injuries may be linked to this medication.
Lawsuit Legal News works with plaintiffs nationwide to evaluate potential compensation for medical costs, reduced quality of life, and lasting auditory harm. We are committed to ensuring those affected have access to the information and representation they need.
Call us at (866) 535-9515 to speak with an attorney for a free case review, or fill out our secure online contact form. There is no obligation, and we do not charge fees unless we recover compensation on your behalf.
Don't wait any longer, call 866-535-9515 or submit your case for review today!