Hearing Care Interventions and Cognitive Decline: Landmark ACHIEVE Study Results Explored

Results from the Aging and Cognitive Health Evaluation In Elders or the ACHIEVE study were recently shared. The initial findings from this undertaking revealed that for older adults with increased risk for cognitive decline over a three year period, hearing interventions slowed thinking and memory abilities by 48% over a non hearing intervention. Joining me today to discuss the achieve study and its early implications on hearing care are Dr. Shannon Basham, she’s senior director of audiology and education at Phonak, and Dr. Victoria Sanchez, chief of audiology, Department of Otolaryngology, University of South Florida, where she’s also the principal director of the auditory Rehabilitation and Clinical Trials Laboratory. Well, ladies, thank you so much for joining me this afternoon. So, the first question is the ACHIEVE study. People have talked about it, people have heard about it, people know that it exists. But before we dive into the results, what exactly is the ACHIEVE study and what is kind of the foundation for undertaking this large long term study? Well, I’ll start as one of the investigators of the ACHIEVE study, it’s going to be hard for me to try to give you a short, brief answer to that, because it’s been something we’ve been working on for over ten years, and lots of research will before that, in between that as well. So the achieve study was spearheaded by principal investigators Frank Lin and Joseph Coresh and brought in eight institutions to help design, run, and now analyze the ACHIEVE study results. So, ACHIEVE, as you mentioned, stands for the aging and cognitive health evaluation study. It’s this first of its kind because it’s a long term, randomized, controlled trial to look at the effects of best practice hearing intervention on the effects of cognitive decline. So, like I said, we’ve been working on the study for over ten years. just recently, this past July, we were able to release the study results of the main trial outcomes. ACHIEVE is a gift that keeps on giving. There’s still so much data that we are analyzing and that we need to get out to the community. but at this time the study was a success in the fact that we were able to demonstrate in a randomized, long term trial for the first time that hearing intervention had a positive influence, that we saw great hearing outcomes and we saw reduction in cognitive decline in those that were more at risk. Yeah, and the findings are really, really remarkable. And I think it was. Would help the audience if we knew just a little bit about what that methodology was that led to these results. So, can we share a little bit about that, please? Sure. Let me start with the design of the trial. So, it was a randomized control trial, meaning that we were going to have two groups randomly assigned to two different interventions. But before we randomly assigned our participants, we have to talk about how we got our participants into the study. So, we had very specific inclusion exclusion criteria. We wanted individuals who are older, who had untreated hearing loss, meaning that they were not hearing aid users and that were cognitively intact, they had normal cognition. those individuals were recruited through two methods. We recruited them through a long standing heart study known as the ARIC study. These are individuals that have already been followed for many, many years and then also through community outreach by clinicians referring into the clinic by individuals actively seeking research opportunities. So we recruited through those two routes. We brought in 977 individuals who were then randomized to the two interventions. The first intervention was the best practice hearing intervention, which I love to tell you much more details about that, but I’ll keep that one short for now. The comparator control intervention was a successful aging intervention. So, it’s an intervention that is based on the ten keys of healthy aging from the investigators from the University of Pittsburgh. And in this intervention it controlled time with a professional and also provided information about successful aging tips. So our participants were randomized to either intervention and then seen every six months for the next three years. Our primary outcome was then obtained at that end of that three year period where we were then able to look at an attempt to treat everyone enrolled, everyone altogether if there was a benefit of the hearing intervention, and the fact is, this was actually a null finding when everyone together was evaluated, hearing intervention did not show to be any different from our control successful aging education intervention. But we knew that our recruitment groups were different because we brought in individuals from that long term health hearing – or heart study, as well as individuals from the community. So, when we look specifically at that ARIC population, they were older, they had more risk of cognitive decline, risk factors for cognitive decline, and we were able to see in that specific group a significant reduction in cognition over three years with the use of the hearing intervention. Now, why we think we didn’t see it across all of our participants in the overall analysis is because in our healthy volunteers that joined our study, there was actually very little cognitive change over three years. So it’s very hard to slow something down that’s already very slow. So what we think, and is why we’re going to continue on with this investigation is that maybe three years just wasn’t enough to see the full benefit of the hearing intervention. Does that help answer some of the methodological design of the study? Absolutely. What I want to touch on here for our clinicians is you all use best practices. And I guess in some of the conversations that I had informally with some of the audiologists that participated, without these best practices, there’s a possibility that you wouldn’t have seen the strength of the outcome that you saw. So can you talk a little bit about the best practices and how they were implemented within this study? Sure. So, best practice hearing intervention that was used in the ACHIEVE study started many years ago, too. So it took a process to what is best practices? Define that. Right. so a group of researchers spearheaded by the University of South Florida, Terry Chisholm, Michelle Arnold and myself we took to the literature, we looked at the professional guidelines that were available. We evaluated other research. We brought in a group of researchers from academic settings and industry settings and master clinicians to all come together to vet what would be considered best practices if you were to design the best hearing intervention possible. What should we be doing? And from that, we came out with an initial outline of what our best practice measurements would be and how to go about doing them. We completed a feasibility study to evaluate them. We then transferred from a feasibility study over to a pilot study at Johns Hopkins. And at this point, a couple of years later, we then had the final version of the best practice hearing intervention. And I give you all that information because it wasn’t just, hey, this is what we’re going to do. We’re going to go ahead and do it. Even our best practice was evidence based. We knew exactly what we were going to do, how we’re going to do it, evaluate it for its feasibility to be used in the trial, and then it was ready to be used in the study. So what it includes is a comprehensive evaluation, so, thoroughly evaluating the auditory system including case history, including audiometry, speech in noise testing, tympanometry, et cetera, to get a full evaluation of the auditory function. it also then included a needs assessment based off the COSI goals, where we were able to evaluate and prioritize the top three listening needs of an individual using the audiological findings as well as the Needs Assessment. We were then able to design the most appropriate technology to be used by those individuals to meet those needs. And that included not only hearing aids, but also hearing assistive technology to work with the hearing aids. we collected outcome measures across the way, making sure that the intervention that was patient centered, yet standardized was appropriate for the patient patients. and then throughout all of these, this was conducted over four different sessions, intervention sessions. We had self management support providing patients with education about their loss, how best optimize their hearing intervention, and how best they can be the best user of the technology that was provided to them. Yeah. it’s remarkable what you guys have done in terms of putting everything together, cross checking it, and then the outcomes that you you know, as a researcher myself, I think it’s tremendous what you all have done. And then Phonak was kind enough to donate or provide in kind devices. So, Shannon, can you talk a little bit about how you all partnered with this study and the devices that were provided for the actual study itself? Certainly. I mean, thank you again so much for inviting us to be here today. At Phonak, we have been invested in this conversation around how hearing healthcare maps and informs the overall health value for years and years and years. So we have looked at the way hearing health care has influenced well hearing as well being, well being, meaning physical well being, emotional, social, emotional well being, as well as cognitive well being. And so we got involved early when we saw the opportunity to move this research forward. We didn’t want the lack of devices to be kind of a hang up in this super important research that’s moving forward right now. And so, yes, we worked with Vicki and her team to provide this inkind donation of all the devices and accessories. And the devices and accessories weren’t just blank slate. They truly were chosen for the individual at hand. So it was based on person centered care. And so we provided a little bit of training for the staff and then the devices and accessories for all the participants. Well, let me ask this, because I think there’s a little bit of for lack of a better term, kind of a spin in the industry that only a certain type of device is going to help with cognition. And so we’ve got some talking heads in the space that are saying that you just mentioned. That you fit the best devices for that individual. So whether it was economy, whether it was premium, or anything in between. So can you talk a little bit about that, please? Let you take that, Vicky. Sure, I’ll definitely take that. Because it’s important to note that we did have 977 individuals in the study first were randomized to receive the hearing intervention. So that’s over 400 individuals that received the initial hearing intervention. And we had a very unique requirement. We needed that hearing intervention to be as similar across individuals, but also meet every patient’s individual needs. so any clinician that may be watching is well aware that all patients are different. They all have different needs. They all come with things that are important to them, different types of findings from their audiological testing. And so it’s quite the challenge so having technology that can meet everyone’s need, but still be a very standardized approach. So the intervention has similar dose regiments to it. Right. Because this is a randomized control trial, we have to reduce all of noise and variables that we don’t want to influence our study results. So the way that we tackled this in the ACHIEVE trial was what I was describing to you early with the best practice of approach. So we made sure to fully evaluate every single patient for their audiological abilities and also their needs. With that information, we were able to then say, well, what level of technology would be best to support that individual needs? and then we were able to provide that level of technology and make sure that it was definitely meeting those needs through either self reported abilities, but also aided speech in noise testing and so forth. So to give you a good example, if we had one patient who had more milder hearing loss, the majority of their listening goals included communicating in quieter environments or listening to the television. That patient’s needs probably could be served with the 50 or 70 standard or lower technology coupled with maybe a tv link in order to bring their tv in one of the most important listening environments to them, directly to their ears. Another example would be an individual who had maybe a more severe sloping sensorineural hearing loss, extreme difficulty hearing and background noise based on measurement of speech in noise ability. and their major complaints was being able to hear in complex, noisy background environments in a work setting or a social setting. And for that individual, we maybe decided that maybe the premium technology would be best to meet their needs, along with maybe a Roger FM system or some other technology to really improve that signal. Noise ratio. So that’s an example of how we designed a protocol to make sure everything was done the same across each individual. But the right technology was coupled to the patient’s needs, as well as all the education was in place in order to make best use of those devices. I think it’s really important that a lot of people have mentioned that this was a hearing aid study. And although we had excellent devices in this study, this was really a study of best practice audiological care. The importance of the audiologist deciding the technology, verifying that it was working through real ear verification, electro-acoustic analysis, all of those things were to ensure the technology was as best as it could be used by each patient. Yeah, and you just brought up a really interesting point. And going back to best practices, we’ve had real ear available now for 30, 35 years, and we still have a minority that utilizes this. And so I guess my question to you, and it may be a little bit of a loaded question, and that is, if you had just fit first fit would you have seen the same outcomes if you had to fit first fit and not done the real ear verification that you just mentioned? Well, my scientist response would be, we didn’t do that study. We would need a study to look at best practices compared to another intervention that maybe did not include all of the elements of best practice, that didn’t include what I think is crucial, like real ear and so forth. So in order to truthfully answer that study, that study needs to happen still, right. And that’s nice about ACHIEVE is that we still have a lot of way to go. We need to do additional studies to determine exactly what about an intervention is crucial for the most success. that would lead to positive cognitive outcomes as well. my clinician answer and my hypothesis of what I think would happen is I don’t think that we would have seen so much success with our hearing intervention if we did not include all of those best practice elements. if we weren’t ensuring that each patient’s needs were being met, if we weren’t doing the real ear verification and the electroacoustic analysis and all of those things that should be included in best practices. I don’t think that we may have seen as high quality as satisfaction, use, and wear time, and we’re still trying to figure out how much do those things potentially influenced the overall cognitive results. Right. so we do know that majority of our patients wore the hearing aids for eight to 10 hours a day. they self reported satisfaction and improvements in their health related quality of, for these devices. but we still need to do additional analyses on. Our data set. What about the ones that wore them less? What about the ones that reported less satisfaction and usage? did they not have as much of the outcomes that we’re looking at? What I appreciate about your comment here is that we still have a lot of unknowns, even though we have this wonderful outcome and there’s a lot of variability and variance in how people perform with these devices that we still need to understand. And I think one of the things that you mentioned early on is that the ACHIEVE study is an ongoing study in order to continue to answer some of these questions that keep surfacing. Yeah, that’s right. So we’ve only so far published our primary analysis. we have tons of secondary analyses papers that are being written as we talk. we have data sets that are being analyzed by our statistical teams right now so we can get information from this original trial out to the community. but we also have additional studies as well. So since we did not see the primary outcome of hearing intervention across all of our participants, we hypothesized that we need a longer time frame. Maybe three years just wasn’t enough. So we have designed a long term follow up study where we’ve continued to follow our individuals for an additional three years beyond the initial three years. So six years of looking at the effects of hearing intervention. We’ve also now provided the other group, the group that was originally randomized to receive this successful aging control intervention. They’ve now received hearing intervention with a blended telehealth model. So we’ll be able to look at the data with conventional in office versus telehealth blended models. We’ve also embedded a randomized control trial into the control trial to ask additional telehealth questions. So this is what I mean by we have so much to study. We’re studying it now, and we’re going to have so much more to report on overall hearing intervention in this ACHIEVE study group. And that’s fantastic. And on the manufacturing side, Shannon, as these results are coming out, I would assume that Phonak has some built in offerings that they’re going to be providing clinicians. Can you talk a little bit about. Sure, for sure. I mean, it’s no question this is super exciting times, right? We’re seeing unprecedented amount of just media involvement and buzz around how hearing health care really affects that overall health value and has a downstream effect on someone’s social emotional well being. And we know what social emotional well being and social isolation can do to someone’s overall general health. So, of course, we have been a part of all of this from the beginning and had an idea of this pathway in how to get this information out there and get the information out in a socially responsible way. when the media started buzzing about all of this, we got a remarkable amount of influx from our customer base asking game for, hey, we need some in clinic success tools, like, how do we have these conversations? How do we land the conversation with a patient in a way that’s meaningful, impactful, and doesn’t involve scare tactics that has that really favorable, constructive message behind it? And so we have partnered with ADA and we’ve partnered with the scientific community to put together this robust training program for HCPs that they can go through. It’s called ECHHO, which is enhancing cognitive health via hearing optimization. That is a mouthful, right? But it’s easier to say ECHHO. And so the ECHHO training program will be available very soon, in mid January. But as part of that ECHHO training program, we also have some in clinic success tools that help drive those conversations, some of those that you can have with your installed base of patients, as well as community outreach initiatives. The things that are going on right now in hearing care are just tremendous. And as I’m towards the end of my career and I start to see what’s going on, I kind of wish I could go back 20 years, but that’s not going to happen. for those individuals that are just coming into this space, what would you say to them, given what you know and where we’re headed, at least from what you can see, what would you say to these individuals? Oh, my goodness. like I said, it’s super exciting times when you look at just how the population is growing and our patient base is growing, and there are so few of us out there, and so the demand is just increasing over and over. And one of the things I would really like to highlight is the importance of having that multidisciplinary support system for hearing healthcare providers. I think that how we reach out to physicians and allied health professionals and how we create that network of professionals to help overall fit that overall human in front of us and not just look at ears and head and neck, I think it’s super important moving forward. Absolutely, Vicky. And I would add to that because that’s also what was so challenging about designing ACHIEVE, too. We needed to make sure we had individuals and expertise across many domains in order to. To make the achieve study successful. We have physicians, we have gerontologists, we have epidemiologists, we have experts in cognition and neurocognition. And all of these different individuals had to come together to put together ACHIEVE study, and they continue to monitor and review and interpret the results that are coming out of the achieve. So just in a study, we needed this disciplinary approach and just like everyday clinics need this interdisciplinary approach, too, to manage our patients. Because like you said, Shannon, we’re not just ears, we’re whole bodies. and we know we need to take care of our whole body, including the ear. Yeah. So, Shannon, let me ask you this, because this just popped into my head. Is it only for Sonova customers, or is the ECHHO program available to any hearing healthcare professional? Absolutely not. Amyn, any hearing healthcare professional. This is a topic broader than just Sonova and broader than just Phonak. We have undoubtedly spearheaded a lot of the conversation and tried to move it forward, like I said, in a very socially responsible way. But we engage and invite people to have this conversation, and so, as anyone who is interested can absolutely reach out, and we’re more than happy to have them participate. Wonderful. Thank you, ladies. It’s been a great conversation. I always learned so much from the both of you. And again, as I said earlier, I wish I could go back 20 years so that I could immerse myself in all of this. And as a former educator, I think there’s a huge need and I think we’ll see this in the near future for changing how we educate our students into this more whole body comorbidity kind of a paradigm here. but it’s really exciting. And to both groups, the manufacturing side and the scientific and academic side, thanks for all the hard work that you guys do, continue to put those papers out, help us help our patients do with the things that they need to do. And I’m hoping in the short term rather than in the long term, that we can get you guys back on after you’ve got four or five more papers published. And we know a little bit more about how to treat these individuals and give them the quality of life that most individuals deserve as they age into their graceful retirement components. Thank you so much for this opportunity. I do hope you do ask me to come back and we can talk much more about all of our ACHIEVE results. 100%. Absolutely love that. And Shannon, as well as the ECHHO program, continues to evolve and it continues to grow, we’d love to have you guys on and share what that evolution looks like, because I think. I don’t think I know the information that’s going to be available to those practitioners. Is going to help them again with the treatment intervention that they’re going to provide 100% and happy to be here and would love to come back.