Lenire Shows Consistent Positive Results for U.S. Tinnitus Patients in 2nd Peer-Reviewed Real-World Study

Lenire Shows Consistent Positive Results for U.S. Tinnitus Patients in 2nd Peer-Reviewed Real-World Study

PR Newswire

  • 81.8% of patients with bothersome tinnitus treated with Lenire at New York Hearing Doctors reported significant improvement in a real-world clinical setting.1,2
  • Patients with bothersome tinnitus reported a 23.8 point mean reduction in tinnitus as measured by the Tinnitus Handicap Inventory, which is greater than three times the threshold for clinical significance.1,2
  • The majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus following 12-weeks of Lenire.1,2
  • This evidence is consistent with the first real world analysis of U.S. tinnitus patients treated with Lenire that was peer-reviewed and published in Nature Communications Medicine.3

NEW YORK, Feb. 17, 2026 /PRNewswire/ — The American Journal of Audiology has peer-reviewed and published the positive outcomes of U.S. tinnitus patients treated with Lenire, the only FDA approved tinnitus treatment device of its kind.

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Results in the paper titled: «Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms» reported 81.8% of patients with bothersome tinnitus had a clinically significant reduction in tinnitus when treated with Lenire.1,2

These results are consistent with previously published Lenire treatment outcomes3, showing repeatable success for tinnitus patients in real world clinical settings. In addition to being supported by the largest body of clinical trial data in its field, Lenire is now underpinned by the most extensive real-world evidence of safety and effectiveness, following publication of this research in The American Journal of Audiology.

The paper, authored by Dr. Craig Kasper Au.D of New York Hearing Doctors (NYHD) et al, analyzed the results of 140 tinnitus patients who were fitted with Lenire at NYHD between May 1, 2023, and January 19, 2024.

Read the Paper: https://pubs.asha.org/doi/10.1044/2025_AJA-25-00090

Tinnitus is commonly known as ringing in the ears but can manifest as hissing, buzzing, and other persistent sounds. The condition afflicts an estimated 25 million American adults4, with an estimated 2.5 million tinnitus patients living in New York alone.5

Lenire uses bimodal neuromodulation to treat tinnitus. Bimodal neuromodulation is the simultaneous stimulation of two nerves for therapeutic purposes. Lenire plays audio tones via headphones while delivering mild energy pulses to the surface of the tongue to treat tinnitus. Under the care of an audiologist with tinnitus expertise, patients with bothersome tinnitus typically use the device at home for two 30-minute sessions daily for approximately 12 weeks.

Results Consistent with Real World Research and Clinical Trials

This paper is the second in a series of planned, real-world evidence publications that have been compiled from thousands of U.S. tinnitus patients that have been successfully treated with Lenire.

The analysis found that at the interim check-up, after six weeks of treatment with Lenire, 72.6 percent of patients with bothersome tinnitus had a clinically meaningful reduction in tinnitus.1,2 After 12-weeks, 81.8% of patients with bothersome tinnitus had a clinically meaningful reduction.1,2

Patients reported a mean reduction of 23.8 points on the Tinnitus Handicap Inventory (THI) after 12-weeks, greater than three times the threshold for clinically significant reduction.1,2 As a result, the majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus following 12-weeks of Lenire, according to tinnitus severity grading guidelines.1,2, 11

«New York Hearing Doctors stay on the cutting-edge of tinnitus care through the introduction of modern technologies like Lenire and leveraging research to consistently refine our treatment methodologies,» said NYHD founder, Dr. Craig Kasper, Au. D. «The combination of our personalized approach to tinnitus care and the remarkable effectiveness of Lenire, we are seeing life-changing treatment outcomes for our patients.»

«Lenire was nothing less than a game-changer in my life. I went from debilitating, almost catastrophic tinnitus, that required medication to treat the depression and anxiety, to being able to enjoy life again after four months of Lenire.» said Richard Bistrong, tinnitus patient at New York Hearing Doctors, «Three years later, I can enjoy my life and not worry about my tinnitus. This has impacted not only my well-being but my loved ones as well. For anyone that is looking for relief, that is based in science and patient results, I would encourage you to seek your local Lenire Provider as soon as possible to learn more about Lenire.»

The evidence in this paper is consistent with the first peer-reviewed real-world analysis of U.S. tinnitus patients treated with Lenire and Lenire’s large-scale clinical trials.3,6,7,8

The first real world analysis of U.S. patients treated with Lenire, which was peer-reviewed and published in Nature Communications Medicine, showed that 91.5% who used Lenire had a clinically significant reduction in tinnitus after 12-weeks of Lenire.3 This consistency demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting.

FDA Approval in March 2023 was facilitated by Lenire’s controlled, TENT-A3 clinical trial. The results were published in Nature Communications, a journal from the same portfolio. The paper remains in the 99th percentile of more than 250,000 tracked Nature articles.

TENT-A3 included 112 trial participants and demonstrated Lenire’s clinical superiority to sound-only therapy, a widely used treatment for tinnitus. Nearly 89% of trial participants said they would recommend Lenire as a tinnitus treatment.6

According to Neuromod Devices founder and CEO, Dr. Ross O’Neill, who was Lenire’s principal inventor, «The consistency of the real-world outcomes of US tinnitus patients treated with Lenire with our large-scale clinical trials demonstrates the replicability and scalability of Lenire as a tinnitus treatment option for the over 740 million people worldwide living with tinnitus.»

«By working closely with our network of providers, we are seeing market-surpassing patient outcomes, improving clinical best practices, and a rapidly growing body of robust real-world evidence positioning Lenire and bimodal neuromodulation as a leading tinnitus treatment option.»

Lenire is available through specialized tinnitus clinics in the United States of America and Europe. Lenire is also a treatment option through the US Department of Veterans Affairs.

References and Notes

  • Kasper, C et al. Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms, American Journal of Audiology, https://doi.org/10.1044/2025_AJA-25-00090 (2025)
  • As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories.
  • Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). https://doi.org/10.1038/s43856-025-00837-3
  • https://www.nidcd.nih.gov/health/tinnitus
  • https://www.nyc.gov/assets/doh/downloads/pdf/survey/survey-2013noise.pdf
  • Boedts, M. Beuchner, A. et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nature communications (2024)
  • Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
  • Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.
  • US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/
  • Zeman, F. et al, Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? https://pubmed.ncbi.nlm.nih.gov/21493265/ (2011) Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper.
  • A. McCombe et al., Guidelines for the grading of tinnitus severity, Clin. Otolaryngol. 2001, 26, 388 – 393
  • About Neuromod

    Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions.

    The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com.

    About Lenire®

    Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.

    Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire, was developed by Neuromod Devices. It consists of wireless (Bluetooth ®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli.

    The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing treatment from home. Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

    Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA.

    About Tinnitus

    Tinnitus, which is commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus.3 Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 3.2 million veterans compensated in 2024.9

    About Dr. Craig Kasper Au. D.

    Dr. Craig Kasper, Au. D. is the founder and managing director of audiology clinic, New York Hearing Doctors | Institute for Hearing and Balance and New York Hearing Doctors | Tinnitus Care, based in New York.

    He earned his Doctorate of Audiology from the University of Florida and holds a master’s degree with clinical honors from the State University of New York at Buffalo.

    Dr. Kasper’s extensive experience includes a Clinical Fellowship and clinical practice in the Department of Otolaryngology/Head & Neck Surgery at New York-Presbyterian Medical Center. A Distinguished Fellow of the National Academies of Practice, he is also a Fellow of the American Academy of Audiology (AAA), and a member of the Academy of Doctors of Audiology (ADA).

    Dr. Kasper’s contributions extend beyond clinical practice; he has authored scholarly articles published in prestigious peer-reviewed journals such as Hearing Research and Laryngoscope and has been an invited presenter for professional conferences since the start of his career. Committed to public health education, he has also frequently served as a resource for the popular media on topics related to hearing health and wellness.

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    0 responses to “Lenire Shows Consistent Positive Results for U.S. Tinnitus Patients in 2nd Peer-Reviewed Real-World Study

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    6. Tengo varias preguntas sobre esto a ver si me podiais aclarar:
      -¿Puedo hacer un ingreso regular de 800 euros y me cobran 0euos de comisiones y mto.?
      -¿Puedo sacar el dinero cuando quiera?,¿todo ó tengo entendido que hay que mantener un mínimo de 100 euros los 30 meses?
      -No necesito pero me obligan a sacar una tarjeta de débito que me cuesta 11 euros el primer año y 22 euros la renovación, también otra de credito que me cuesta 0 euros el primer año y 35 euros la renovación.
      ¿Hay que mantenerlas 13 meses?
      ¿Puedo cancelar alguna de ellas desde el principio?
      ¿Puedo cancelar alguna de ellas antes de la renovación?
      ¿Hay alguna tarjeta de credito más barata?
      Aparte de la cuenta nómina he visto que también que para que te den la tv también se puede sacar una cuenta tarifa plana básica o personal, ¿sabeis algo de estas cuentas?¿que requisitos tienen?
      Muchas gracias a todos por responder

    7. Yo fui a informarme y te cuento. Únicamente admiten los ingresos regulares en el caso de que seas autónomo. Te abren una cuenta Tarifa Plana Cero que está exenta de comisiones y presenta alguna ventaja más. Sobre dejar un mínimo de saldo en la cuenta no es necesario, pero sí te obligan a mantener varias tarjetas durante los 30 meses con un coste aproximado de 100 euros anuales.

    8. hola buenas!
      me llamo javi y estoy dudando de que banco, me puede dar mas beficios, sin sorpresas por domiciliar la nomina, ya que llevo años en la caixa y no me da nada ningun beneficio. es mas me rechazan los prestamos que solicito, ni siquiera una targeta de credito, por alegan de que siempre esta a cero la cuenta, yo cuando cobro la nomina dejo el dinero para los pagos, y saco el resto, pues no me fio, de que un dia me quede sin dinero, ya que esta todo muy mal, corre riesgo mi dinero o mis ahorros en el banco?? muchas gracias y un cordial saludo.
      javi

    9. NO TE EXTRAÑE QUE NO TE DEN LOS PTMOS, PORQUE LO QUE VEN ES QUE NO TIENES CAPACIDAD DE AHORRO PORQUE SIEMPRE DEJAS LA CTA. EN MINIMOS, ASI NINGUN BANCO TE LO VA A CONCEDER. TAMBIEN ES VERDAD QUE LA CAIXA, COMO TANTAS OTRAS CAJAS, TIENE EL PUÑO CERRADO PARA LOS RIESGOS, PARA REMONTAR. NO TE PREOCUPES, QUE POR UNA NOMINA NO CREO QUE NINGUN BANCO SE COJA LAS MANOS. LOS QUE SE TIENEN QUE PREOCUPAR SON LOS QUE TIENEN DÉPÓSITOS Y FONDOS EN BANCOS DE DUDOSA ACTIVIDAD. LA GENTE SE PIENSA QUE PORQUE LES DEN UN 7% YA ES UN GRAN BANCO Y SE EQUIVOCAN. LO QUE LES PASA ES QUE EL BANCO DE ESPAÑA LES PRESTA EL DINERO MAS CARO Y POR ESO OPTAN POR CONSEGUIRLO EN EL MERCADO MONETARIO, Y SI EL BANCO DE ESPAÑA NO SE FIA DE ELLOS, VA Y SE FIA LA GENTE. QUE LOS BANCOS NOES LA ADMON PUBLICA, ABRAN OS OJOS.

    10. Hola , cuando vallais al banco queos dejen lo que hay que pagar de irpf y de iva sobre el valor de la tele ya que en la mayoria de bancos esto no lo dicen y luego llagan las sorpresas .A mi ya me ha pasado con la promoción del portatil y nunca me hablaros de esto . Cuidado

    11. Yo he estado calculando y la tele entre unas cosas y otras te sale sobre unos 250euros que tampoco regalan tanto .Hay oficinas en las que han dado la occión de poner un dinero a plazo fijo a 12meses de 9300euros o 6800euros a 18 meses.

    12. No es ningún chollo. Te obligan a contratar dos tarjetas de crédito que tienes que pagar porque las tienes que mantener 13 meses por lo menos y además llevan unos costes desproporcionados si las utilizas. En total, no usando las tarjetas y anulándolas una vez cumplidos los 13 meses puedes ahorrar unos 38 euros con respecto al precio de ese televisor en una gran superficie. Y además luego vendrá que te cobran para hacienda la retención correspondiente, por lo que probablemente incluso en las mejores condiciones te cueste más que si ahorras un poco y lña compras directamente.

    13. Creó que teneis toda la razón, que aqui no te regalan nada, ya que a mí me paso con unas sartenes que regalaban el banco bilbao, que al final entre el irpf y el descuento de Hacienda, al final me salieron caras, así es que no os tomen el pelo, que al final siempre esta la letra pequeña que es la que nos joroba, por no decir otra cosa.

    14. Yo saque el portatil y ahora me he sacado la TV LCD 32. Estas promos no hay que declararlas. No es obligado domiciliar nomina. Si, meter en la cuenta 800€ todos los meses en un margen de 10 dias. Cero matacero, pero cero,cero, cero de gastos de mantenimiento, ni por recibos, ni por el correo a casa, ni por transfer. Las tarjets gratis el 1er año. Resto fuera. Dadas de baja Menos la de debito. Banesto no pierde nada, ganar, gana clientes que es el proposito de esta promo. Precio de portatil y tv 32 en mercao unos 900€ los 2. En banest 197€. Los hay mejores, nos ha jodio! portatiles a 1200€, TV LCD 32 a 1000€. Señores, son lentejas. Relacion calida-precio-promo es cojonud…….Un saludit a los viandantes.

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    20. hola , no se si llegara mi comentario pero os voi a esplicar. esto es el cuento de la abuela. mira yo tengo el portatil. y he cogio tab la tele, pero sabeis ke?, me ha pasado de todo. os esplico. primero me cobran 74 euros y 25 euros de unas tarjetas que yo no las he visto aparecer por mi casa , me cabreo con el banco. llamo y pido esplicaciones. me dicen que van en la promocion, nunca jamas nadie me informo de las tarjetas, no me devuelven el dinero. me cabreo y me dicen que llame aun numero de tefono para darlas de baja, se pasan los dias, intentamos darlas de baja. largas y larga, que si este numero de tefono que si el otro bla bla bla. conseguimos hablar y nos dicen que tenemos que cambiar el contrato a tarifa plana o no se ke historias, llamando al banco se pasan los dias, largas y largas. me cabreo y estoi por suspender todo, me dicen que si lo quiero cambiar y dar de baja las tarjetas que nunca he tenido. tengo que pagar comisiones cada seis meses de doce y pico euros, y que si no quiero que me cobren comisiones tengo que ir todos los meses al banco a hacerlo yo, ufffffffffff.aun hay mas. me dan de baja y me hacen la tarifa plana, se equivocan un monton de veces. me hacen pasar muchos cabreos.y al final cuando llego a casa me han cobrado 25, 50 euros. y llamo por telefono y se lo digo , me dicen claro por dar de baja la otra cuenta , la madre que los pario. ladrones. o sea os digo que la tele no sale regalada, se la cobran y muy bien cobrada , nadie da nada por nada. en cuento termine de pagar lo que debo quito todas las cuentas del banesto.espero que alguien me lea y que me conteste gracias .

    21. Banesto ha jodido a mi marido y a un amigo tambien. Para mi, despues de Banco de Andalucía son los peores. Y quieran creerlo o no ni la television ni el portátil te lo regalan.. como no cumplas cualquiera de las reglas te sancionan con 300 y pico de euros.. porque nos hemos mudado de casa y los recibos domiciados se cortaron «temporalmente» la sancion fue de mas de 300 euros.. y el cabreo q te llevas cuando ves lo q te han descontado y luego para ir a reclamarlos.. y como te tratan !! en fin.. espero que Banesto sea lo primero en undirse en el fin del mundo!!

    22. CHOLLO!!!!!!!!!JAJAJAJAJA…….NO ES NINGUN CHOLLO!!!!!!! te cobran 100 € de gastos de manipulacion, mas 150 € en tarjetas durante 2 años, mas 6 € mensuales de mantenimiento de cuenta durante 30 meses, total que pagas 630 Euros por un ordenador o una TV que su valor seguro que no llega a 500 €. Y encima si vas a cancelar la cuenta cuando cumples los 30 meses requeridos te hacen esperar dos horas para decirte que no tienen linea de telefono para dar de baja la cuenta, cosa que no para nunca cuando vas a contratarlo. Y del trato que dispensan….., es el mismo que si vas con un fajo de billetes de 500 € por los CO-JONES

    23. Banesto «premia», menuda falacia…
      No hay ningún banco que premie a nadie.
      BANESTO NECESITA NUESTRAS NÓMINAS, Y EN CUANTO VAS UN POCO JUSTO, COMO BUENOS JUDÍOS Y ÁVAROS QUE SON, TE ACOSAN Y MACHACAN, Y TE SACAN HASTA LAS ENTRAÑAS EN COMISIONES.
      DESPUÉS EL ESTADO APOYA A LOS BANCOS, CON LA EXCUSA DE QUE SI CAEN LOS BANCOS CAEMOS TODOS. LOS BANCOS NECESITAN UN BOICOT DE VEZ EN CUANDO, PARA QUE NO NOS RESTREGUEN POR LA CARA SUS BENEFICIOS.

    24. POR CIERTO, LO QUE MÁS FASTIDIA A UN BANCO ES UNA RECLAMACIÓN EN LA OFICINA DEL CONSUMIDOR Y OTRA AL BANCO DE ESPAÑA.
      ES POR DAR PISTAS…