If you have a certain kind of hearing loss for which hearing aids provide limited benefit, a new solution may improve your ability to hear and understand.
The Food and Drug Administration (FDA) recently approved the first implantable device for people who have severe to profound sensorineural hearing loss of high-frequency sounds, but can hear low-frequency sounds with or without a hearing aid.
Individuals with this type of hearing loss have historically been very difficult to fit with hearing aids, because their hearing for different pitches is so drastically different. They can hear low pitches fairly well, so the volume of speech generally is not a concern. But the patient may have such severe hearing loss with the higher pitches, which give speech clarity and meaning, that hearing aids cannot provide adequate benefit.
Sensorineural is the most common form of hearing loss. It occurs when the inner ear, or the cochlea, becomes damaged. Aging, heredity, loud noise, drugs that are toxic to the inner ear and some illnesses cause the damage.
The new device, called the Nucleus Hybrid L24 Cochlear Implant System, combines the function of acoustic amplification — similar to a hearing aid — and the electric stimulation of a cochlear implant.
Like a traditional cochlear implant, the device consists of two parts: an external microphone and speech processor that picks up sounds from the environment and an implanted device, with electrodes that send the impulses to the hearing nerve.
Unlike a traditional cochlear implant, the hybrid device is placed only within the section of the cochlea (inner ear) that senses mid-range and high frequencies. Its design improves the possibility of retaining good low frequency hearing. An acoustic component provides stimulation similar to a hearing aid for the low- to mid-pitches.
The combination of electric and acoustic stimulation gives an improved ability to understand speech and a sound quality that hearing aids cannot provide.
The new device is a “game changer” for people with this type of hearing loss, says audiologist Sarah Sydlowski, AuD,PhD. Dr. Sydlowski is Audiology Director of Cleveland Clinic’s Hearing Implant Program.
“People with this type of steeply sloping sensorineural hearing loss often do not benefit fully from conventional hearing aids,” Dr. Sydlowski says. “Although these patients can still hear some low-pitched sounds, their hearing drops off sharply in the higher pitches. This can make it difficult for them to follow a conversation or fully enjoy music.”
People with severe or profound sensorineural hearing loss of high-frequency sounds may have difficulty hearing faint sounds and hearing and understanding certain speech sounds, Dr. Sydlowski says. In some cases, they may have trouble hearing high-pitched emergency vehicle sirens or common safety alarms, such as smoke or carbon monoxide detectors.
The FDA evaluated a clinical study involving 50 people with severe to profound high-frequency hearing loss who still had significant levels of low-frequency hearing. The individuals were tested before and after being implanted with the device.
A majority of the patients reported statistically significant improvements in word and sentence recognition at six months after activation of the device compared to using a conventional hearing aid, the FDA says.
The FDA says the risk of low-frequency hearing loss is a possibility and may be of concern. But the device’s overall benefits outweigh this risk for those who do not benefit from traditional hearing aids, the FDA says.
The FDA says people who are interested in the device should carefully discuss all benefits and risks of the new device with their cochlear implant team.
Patients who are not candidates for the hybrid device still may be candidates for a traditional cochlear implant. An evaluation can determine which approach would be best.