Tag: cochlear implants

‘It’s a great sign’: Innovative Cochlear Implant Trial Expands Earlier than Expected

The new cochlear implant is implanted invisibly under the skin, unlike this standard design. Photo by Brett Sayles

A highly sought-after clinical trial testing completely under-the-skin cochlear implants is expanding earlier than expected. Promising preliminary results showed no serious adverse events or unexpected device effects.

The Medical University of South Carolina, which has one of the larger cochlear implant programmes in the country, is one of several sites in the United States taking part in the Acclaim study. Three patients were implanted in the first wave of the trial and have been using their devices for at least six months. Now, MUSC has the chance to enrol more.

“New patients are coming this week, and we’re going to resume device placement as soon as possible. We have people flying in from all over the country to be part of the trial as well as South Carolinians,” said Teddy McRackan, MD He’s medical director of the MUSC Health Cochlear Implant Program.

Some participants are traveling to Charleston to get the experimental implants because slots in the 56-person national trial are limited, and they like the idea of cochlear implants without external parts.

The Acclaim implants would be the first such devices to hit the market if they obtain approval from the Food and Drug Administration. McRackan said they use the body’s natural hearing bone movements to detect sound instead of the external microphones used in traditional cochlear implants.

“The trial has made it clear that hidden cochlear implants appeal to a lot of people,” said audiologist Elizabeth Camposeo, AuD. She’s assistant director of the MUSC Health Cochlear Implant Program.

“Seeing our patients going through this trial just feels like such a massive opportunity. I didn’t know how hard we were struggling to overcome the physical stigma of visible implants. There were many patients we screened for the trial who we could help with a traditional implant but who did not want any part of it. These people are profoundly hearing impaired, like 10 out of 10 terrible hearing, and they absolutely would not consider a traditional implant.”

They have plenty of company. Just 5% of adults in the United States who could hear better with traditional cochlear implants have them, according to the American Cochlear Implant Alliance.

To measure the Acclaim implants’ effectiveness, participants will check in for testing at one month, three months, six months, one year and two years after their implants are activated. Implantation requires surgery and then one month for healing before doctors turn on the devices.

Once the implants are activated, Camposeo said researchers will start analysing data about how much sound they detect and how well patients understand speech. “Similar to when you have your eyes checked, how close are you to 20/20 vision, we check sound detection. More importantly, we test speech understanding. We play a word. You repeat it back. We play a sentence. You repeat it back in both quiet and noise, because the world is a noisy place.”

A noisy place, and a place where potentially groundbreaking devices can be developed quickly, McRackan said. “I don’t think anybody thought two years ago that the Acclaim device would be at this point now. I think it’s kind of amazing how fast things are progressing.”

Source: Medical University of Southern Carolina

Hearing Devices Increase Social Connectedness and Reduce Mortality

Photo by Brett Sayles

Hearing loss doesn’t just affect how people hear the world — it can also change how they connect with it. New research from the University of Southern California, published in JAMA Otolaryngology – Head & Neck Surgery, is the first to link hearing aids and cochlear implants, surgically implanted devices that help those with profound hearing loss perceive sound, to improved social lives among adults with hearing loss. 

“We found that adults with hearing loss who used hearing aids or cochlear implants were more socially engaged and felt less isolated compared to those who didn’t use them,” said lead researcher Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine at USC. “This suggests that hearing devices may help prevent the social disconnection and broader health consequences that can follow untreated hearing loss.” 

Hearing loss affects an estimated 40 million American adults, yet many go untreated. When left unaddressed, hearing loss can make communication difficult, leading people to withdraw from conversations and social activities, according to Choi.  

Previous research has shown that over time, social withdrawal can reduce mental stimulation and increase the risk of loneliness, anxiety, depression, cognitive decline and dementia. It has also linked chronic social isolation to biological and neurological changes, including increased brain inflammation and alterations in brain structure.  

“Understanding the link between hearing loss, hearing device use and social isolation is crucial,” said Choi. “Until this study, it has been unclear whether hearing devices could help reverse the isolation.”   

Choi and her fellow researchers conducted a comprehensive, systematic review and meta-analysis of 65 previously published studies, encompassing over five thousand participants, on how hearing aids and cochlear implants affect three key measures: social quality of life, perceived social handicap, which refers to the limitations and frustrations hearing loss can create in social situations, and loneliness.  

The researchers found that adults using hearing devices feel more socially connected and less limited in social situations. They are better able to engage in group conversations and feel more at ease in noisy or challenging listening environments. Participants also reported feeling less socially handicapped by their hearing loss, with fewer barriers and frustrations during interactions and an improved ability to stay engaged without feeling excluded. This increased confidence can help users connect more easily with family, friends and colleagues, leading to stronger feelings of belonging and reduced social anxiety. The study also suggested hearing devices may reduce loneliness, although further research is needed in this area, according to Choi. 

Those with cochlear implants reported the most improvement in their social quality of life. This is likely because cochlear implants offer greater hearing restoration than hearing aids, especially for individuals with more severe hearing loss. As a result, they may experience more noticeable improvements in social engagement once their hearing is restored. 

While it was outside the scope of the study to measure how better social lives relate to improved cognitive outcomes, Choi believes there may be a connection, as previous research has found managing hearing loss may be key to reducing the risk of cognitive decline and dementia. “While our study didn’t directly measure cognitive outcomes, the improvements we saw in communication and social engagement suggest that by restoring clearer communication, hearing devices may help preserve cognitive health by keeping the brain more actively involved and people more connected,” Choi said. 

This research follows a January 2024 study by Choi showing that adults with hearing loss who use hearing aids have an almost 25% lower risk of mortality, suggesting that treating hearing loss can improve lifespan as well as social quality of life.  

“These new findings add to a growing body of research showing that hearing health is deeply connected to overall well-being,” said Choi. “We hope this encourages more people to seek treatment and helps clinicians start conversations with patients about how hearing devices can improve their quality of life.”

Source: University of Southern California – Health Sciences

New Auditory Brainstem Implant Shows Early Promise

A new study co-led by Mass General Brigham researchers points to a promising new type of auditory brainstem implant (ABI) that could benefit people who are deaf due to Neurofibromatosis type 2 (NF2) and other severe inner ear abnormalities that prevent them from receiving cochlear implants. With further tests and trials, researchers hope it will provide a more effective treatment alternative than what is currently used.

In the new research, published in Nature Biomedical Engineering, scientists at Mass Eye and Ear, a member of the Mass General Brigham healthcare system, collaborated with scientists at the École Polytechnique Fédérale de Lausanne (EPFL) in Geneva, Switzerland, to report on a new class of soft, flexible ABIs that were designed to address the limitations of those currently used. These implants bypass damaged auditory structures and directly stimulate the brainstem’s sound-processing region to restore auditory function.

The new ABI was borne out of a decade-long collaboration between Mass Eye and Ear and EPFL scientists. It features an elastic, multilayer construct that includes ultra-thin platinum electrodes and silicone, a novel design that allows it to conform closely to the brainstem’s curved surface.

Conventional ABIs that are sometimes used in patients with NF2 rely on stiff electrodes that struggle to conform to the curved surface of the cochlear nucleus in the brainstem. That limits their effectiveness to modest benefits, typically providing only basic sound awareness to aid lip reading. The design can also cause side effects like discomfort that discourages long-term use.

The novel, soft electrode design was developed using advanced thin-film processing techniques, allowing for closer contact and more precise stimulation. In preclinical tests conducted in Switzerland, two macaques received the implants and underwent several months of behavioural testing. Results showed the animals could consistently distinguish between different patterns of stimulation – which indicated high-resolution auditory perception, a promising sign for eventual human use.

“While cochlear implants are life-changing for many, there remains a group of patients for whom current technology falls short,” said study co-senior author Daniel J. Lee, MD, FACS, Ansin Foundation Chair in Otolaryngology at Mass Eye and Ear. “Our research lays the groundwork for a future auditory brainstem implant that could improve hearing outcomes and reduce side effects in patients who are deaf and do not benefit from the cochlear implant.”

Source: Mass Eye and Ear

Among Those Eligible, Low Levels of Referrals for Cochlear Implants

Photo by Brett Sayles

A survey conducted in the UK found that people with severe to profound hearing loss who were eligible for cochlear implants were less likely to be referred if they lived in deprived areas and were male.

The study, published in PLOS Medicine, was carried out to determine the rates at which people in the UK with hearing loss were getting correctly referred for implants under the NHS, and where disparities might exist. Referrals were to be made on the basis of meeting pure tone audiometric threshold criteria.

Of 6171 participants in the survey who underwent the pure tone test and already did not have a cochlear implant, only 38% were informed of their eligibility and a mere 9% were actually referred for assessment.

Participants were less likely to be referred if they lived in more economically deprived areas and also within London, were male or were older. In addition to these factors, living in more remote areas, and being Black or Asian also reduced the likelihood of being informed of eligibility.

Lower odds of referrals in economically deprived areas is in line with data from both public and private healthcare sectors in Australia and the U.S.

The researchers also found that the presence of a “cochlear implant champion” increased the likelihood of discussions around cochlear implants but not referrals. That males were less likely to be referred or informed to were interpreted as stemming from men’s differences in health-seeking behaviour compared to women.

Limitations included the observational nature of the study, reliance on accurate documentation of the referring service, and potential underrepresentation of certain demographic groups.