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DURHAM, N.C .– (BUSINESS WIRE) – MED-EL USA today announced that the US Food and Drug Administration (FDA) has approved the company's cochlear implant system for unilateral deafness and asymmetric deafness. This is the first and only time that cochlear implants have been approved for these indications in the United States.
MED-EL cochlear implant (IC) systems, including SYNCHRONY and SYNCHRONY 2 recently approved by the FDA, are now indicated for people 5 years of age and older with SSD who are suffering from a loss. Deep sensory neuro-sensory hearing in a normal ear or normal neuro-sensory hearing loss in the other ear, or in people aged 5 years or older with an AHL, presenting a loss profound sensorineural hearing in one ear and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB between pure tonal averages. No changes to approved devices in the MED-EL CI system are required for new indications.
"People living with one-sided deafness and asymmetrical hearing loss have few technological options to improve their speech understanding, their ability to locate sounds in their environment and their quality of life," Margaret T. said. Dillon, AuD, Associate Professor, Director of Cochlear Implant Clinical Research and Principal Investigator on Clinical Trial SSD and AHL from the University of North Carolina School of Medicine, who was instrumental in the FDA approval. "The difficulty of understanding speech in noise and locating sound are incredibly frustrating aspects of unilateral deafness and asymmetrical deafness, and it was gratifying to be able to demonstrate the effectiveness of MED-EL cochlear implants for help patients find a sound they had disappeared. "
"The historic approval of the FDA today is a significant step forward for those who have experienced unilateral deafness or asymmetrical deafness for too long. My father was living with one-sided deafness, which severely affected his ability to communicate and locate the sound. His experience has been a motivating factor in my choice to become an audiologist. This has a very personal relationship for me, "said Raymond Gamble, President and CEO of MED-EL North America. "This milestone demonstrates MED-EL's leadership and commitment to truly live our mission of eliminating hearing loss as a barrier to communication – including this traditionally underserved population."
People with SSD or AHL need to get a limited benefit from a unilateral hearing aid properly adjusted in the ear to implant. For adults, the limited benefit of unilateral amplification is defined by correct or less than 5% test scores on monosyllabic consonant-core-consonant (CNC) words in silent mode when tested by ear for to be implanted alone. For children, insufficient functional access to sound in the ear to be implanted should be determined by 5% or less badisted speech perception test scores on monosyllabic word lists appropriate for development. , when they are tested in the ear to be implanted alone. Before implantation of a cochlear implant, persons with SSD or AHL must have at least one month of experience wearing a hearing aid, CROS hearing aid or other relevant device and must not have any subjective benefit. .
To get in touch with a MED-EL specialist regarding this new indication, click here or visit http://go.medel.com/ssd-us.
About single-sided deafness (SSD) and asymmetrical hearing loss (LAH)
SSD and AHL can be caused by viral infections, Meniere's disease, or head and ear trauma. In some cases, the causes of SSD or AHL are unknown. According to recent data, 7.2% of Americans report some hearing loss on one side, 5.7% of them with mild hearing loss and 1.5% reporting a moderate hearing loss or worse on one side, accounting for about 4.9 million adult Americans with SSD.1 Until now, the treatment options were limited to hearing aids and CROS systems that provided only limited or no benefit to people with profound hearing loss. ############################################################################################ 39, an ear.
People with SSD and AHL have difficulty hearing in certain listening situations such as noisy environments. These difficulties have a negative impact on communication and social interactions. SSD may negatively affect children's speech and language development and work performance in adults. These difficulties can be attributed to the absence of binaural summation, the observation of the head by the sound opposite to the ear and the inability to locate sounds. Previously available options in the United States, such as CROS hearing aids and bone conduction devices, do not restore binaural hearing in SSD or AHL patients because they only re-route the signal to the ear . These therapeutic options do not restore sound localization or spatial hearing, which means that patients still face significant communication difficulties in their daily lives.
Clinical Trial Data
The approval is based on clinical data from a study conducted by the University of North Carolina at Chapel Hill with 40 participants aged 18 and over to badess speech perception in silent and noisy environments , the location of the sound and the quality of life. The trial participants suffered from unilateral deep sensory loss of hearing in one ear or asymmetrical hearing loss for less than 10 years and routinely used a hearing aid for at least part of that time. All the people participating in the study had also tried some types of current hearing aids to treat the SSD, such as a hearing aid, a bone conduction device or a CROS hearing aid. The subjects were implanted at the University of North Carolina at Chapel Hill with the MED-EL CONCERT Cochlear Implant System or SYNCHRONY as part of this prospective, multiple-dose, non-randomized, non-randomized clinical study. blinded.
Understanding speech in silence:
Both groups of people (SSD and AHL) improved their ability to understand speech silently after one year of using an implant when it was tested with the implant alone. For people with SSD, mean scores when repeating single words silently went from 4% before surgery to 55% after 12 months of listening with the implant. For the group of people with AHL, this same test score improved from 6% to 56% in 12 months. In the opposite ear, their score has not changed over time. When tested with both ears, there was no change from the score before the surgery.
Understanding speech in noise:
When listening to speech in the noise, the SSD and AHL groups improved during the first 12 months of listening with the cochlear implant compared to their unaided scores before the surgery . The average improvement in the SSD group went from 38% to 47% in 12 months on the AZ Bio Test, speech and forehead noise. This group also experienced an average increase from 17% to 53% of the AZ Bio Test when speech was pronounced on the front and that noise was on the side of the normal hearing ear. The AHL group saw its increases go from 23% to 34% when speech and noise came from the front and 6% to 29% when speech came from the front and the noise came from the next to the best ear, also AZ Bio test. .
Find the direction of a sound source:
People in the SSD and AHL groups significantly improved the search for the direction of sound after listening to the cochlear implant for 12 months. To pbad this test, the listeners were sitting in a room with 11 loudspeakers arranged in a semicircle in front of them, and they were asked to show the loudspeaker where each sound came from.
Questionnaires of satisfaction:
The auditors were asked to complete two questionnaires about their experiences of using the cochlear MED-EL implant. After one year of listening, both groups (SSD and AHL) reported an overall improvement in their impressions of speech quality, their ability to locate sounds and overall sound quality (SSQ test), as well as their ease of communication. Hear in a background noise and in environments with an echo (APHAB test).
Cons-indications
Contraindications for SSD and AHL are the same as for people receiving cochlear implants that have bilateral hearing loss, including: if the person is known to be intolerant to the materials used in the treatment. implant; there is no cochlear development; if the individual has an acoustic neuroma; if the cause of deafness is the non-functionality of the auditory nerve and / or auditory pathways; if infections of the outer or middle ear are present or if the tympanic membrane is perforated in the ear to implant; in case of medical contraindications against middle and inner ear surgery and anesthesia, as needed; if anatomical abnormalities are present, this would prevent proper placement of the pacemaker housing in the skull bone, or prevent the placement of the chosen electrode array in the cochlea. In such cases, the use of the cochlear implant should be carefully considered before surgery. if the psychological state of the patient is unstable or if the patient has unrealistic expectations. In addition, long-term hearing loss for more than 10 years is a contraindication for SSD and AHL indications.
About MED-EL
MED-EL Medical Electronics, a leader in implantable hearing solutions, is dedicated to overcoming hearing loss as an obstacle to communication. This privately owned Austrian company was co-founded by industry pioneers, Ingeborg and Erwin Hochmair, whose groundbreaking research led to the development of the world's first multichannel microchip cochlear implant, successfully implemented in 1977. at the base of what is called modern IC today. This laid the foundation for the success of the company's growth in 1990, when they hired their first employees. To date, MED-EL has more than 2,000 employees and 33 subsidiaries worldwide. The company offers the widest range of implantable and non-implantable solutions for the treatment of all types of hearing loss, enabling people from 123 countries to benefit from the gift of hearing with a MED-EL device . MED-EL's global portfolio of hearing solutions includes cochlear and middle ear implant systems, a combined auditory implant system with electrical acoustic stimulation and bone conduction devices. www.medel.com
1 Golub JS, Lin FR, Lustig LR, Lalwani AK. Prevalence of unilateral hearing loss in adults and the use of a hearing aid in the United States. Laryngoscope. 2018 July; 128 (7): 1681-1686.
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