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RSMj – Research Society on Marijuana

The Research Society on Marijuana (RSMj) is a network of scientists with the shared goal of promoting understanding through empirical research of the determinants, correlates, consequences, contexts, and assessment of marijuana use as well as the treatment of problematic marijuana use, including cannabis use disorder.

As a multidisciplinary society, our members represent a variety of perspectives, spanning biomedical, psychosocial, clinical, and socioeconomic approaches and conduct basic, translational, and applied research. We strive to be a society driven by the evidence base addressing all aspects of marijuana use, including the therapeutic applications of marijuana-based compounds and products; recreational marijuana use; and marijuana misuse and addiction.

1.  We are first and foremost a research society. Thus, we are guided by research in the marijuana field, not by any personal or political agenda.

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Real World Evidence in Medical Cannabis Research

Rishi banerjee.

1 Department of Surgery and Cancer, Imperial College London, London, UK

Simon Erridge

2 Sapphire Medical Clinics, UK Medical Cannabis Registry, London, UK

Oliver Salazar

Nagina mangal, daniel couch.

3 The Centre for Medicinal Cannabis, 18 Hanway Street, London, W1T 1UF UK

Barbara Pacchetti

4 Curaleaf International, London, UK

Mikael Hans Sodergren

5 Division of Surgery, Department of Surgery & Cancer, Imperial College London, St Mary’s Hospital, Academic Surgical Unit, 10th Floor QEQM, South Wharf Road, London, W2 1NY UK

Associated Data

Not Applicable.

Whilst access to cannabis-based medicinal products (CBMPs) has increased globally subject to relaxation of scheduling laws globally, one of the main barriers to appropriate patient access remains a paucity of high-quality evidence surrounding their clinical effects.

Whilst randomised controlled trials (RCTs) remain the gold-standard for clinical evaluation, there are notable barriers to their implementation. Development of CBMPs requires novel approaches of evidence collection to address these challenges. Real world evidence (RWE) presents a solution to not only both provide immediate impact on clinical care, but also inform well-conducted RCTs. RWE is defined as evidence derived from health data sourced from non-interventional studies, registries, electronic health records and insurance data. Currently it is used mostly to monitor post-approval safety requirements allowing for long-term pharmacovigilance. However, RWE has the potential to be used in conjunction or as an extension to RCTs to both broaden and streamline the process of evidence generation.

Novel approaches of data collection and analysis will be integral to improving clinical evidence on CBMPs. RWE can be used in conjunction or as an extension to RCTs to increase the speed of evidence generation, as well as reduce costs. Currently, there is an abundance of potential data however, whilst a number of platforms now exist to capture real world data it is important the right tools and analysis are utilised to unlock potential insights from these.

Cannabis-based medicinal products (CBMPs) are a collective term to describe a preparation or other product that contains cannabis or its derivatives for medicinal use in humans [ 1 ]. There are significant barriers to the integration of CBMPs within treatment pathways including ongoing stigma, cost, education, complex pharmacology and a paucity of evidence to inform international and national guidelines [ 2 , 3 ]. Limited evidence, does, however, support the role of CBMPs in conditions such as chronic pain, neurological disorders, and psychiatric disease [ 4 ]. There is also growing evidence of side effects and how the severity and incidence of side effects may differ between patients [ 4 ]. The quality of evidence, however, is often insufficient in the opinion of insurers, regulators, and guideline bodies [ 5 ].

The National Institute for Health and Care Excellence in the UK has only recommended licensed CBMPs for a limited range of indications [ 6 ]. Changes to scheduling as recommended by the World Health Organisation, and within individual countries, recognises the potential medicinal value of cannabis and removes barriers for clinical and research use [ 1 , 7 ]. However, widespread stigma, complex pharmacology, funding, and challenges in sustaining adequate supply of consistent products continue to act as barriers for clinical research.

Randomised controlled trials (RCTs) are necessary and should continue to be the standard against which medical evidence is upheld. However, they are expensive, time consuming and subject to their own limitations [ 8 ]. Whilst these are awaited, there is a requirement to generate evidence of potential benefits and harms to inform policy and clinical practice.

Barriers to Controlled Clinical Trials for Medical Cannabis

RCTs are not infallible—they are expensive and time consuming. Globally $100 billion USD is spent on biomedical research [ 9 ]. In the UK, the National Institute for Health Research (NIHR) provides £80 million GBP in funding for clinical trials [ 10 ]. Yet, their narrow scope can lack ecological validity to real-world circumstances and therefore lack generalisability in more diverse populations. There are also specific barriers to conducting RCTs using CBMPs.

Complex Pharmacology

In addition to cannabidiol (CBD) and (−)-trans-Δ 9 -tetrahydrocannabinol (THC) there are over 140 cannabinoids, as well as flavonoids, terpenes, and other compounds within the flower of different cannabis plants [ 8 ]. These can each potentially affect the clinical outcomes observed between CBMPs due to their individual and collective effects [ 11 ]. The concentrations of each compound are influenced by the genetics and environment each plant is grown in producing a distinct chemical profile. The result of a clinical trial for one finished pharmaceutical product, therefore, cannot be extrapolated to all CBMPs, due to their heterogeneity. However, current evidence reviews often fail to account for this [ 12 , 13 ].

The route of administration further affects the pharmacokinetics of CBMPs and the associated outcome of any trial. CBMPs can be administered sublingually, trans-dermally, via inhalation, or orally [ 14 ]. This subsequently affects the distribution, biotransformation and elimination of active compounds. Heat exposure and vaporisation of dried flower or extracted oils changes the underlying phytocannabinoid composition compared to the original unprocessed dry flowers, increasing the proportion of decarboxylated cannabinoids [ 15 , 16 ]. Assessment of efficacy using RCTs in isolation will therefore ultimately fail to identify the most appropriate CBMP for each clinical scenario [ 17 ].

Placebo-control

An appropriately blinded assessment against placebo or active therapy is the optimal design for RCTs. It has been difficult to identify a placebo that cannot be distinguished against an active CBMP according to absence of both vasoactive and psychoactive effects, as well as the typical aroma associated with cannabis [ 15 ]. This presents a challenge to adequate blinding.

Production methods and import costs mean that CBMPs are typically expensive, adding further to high research costs [ 18 ]. Research has therefore focused on compounds under patent as opposed to generic CBMPs where research outcomes fail to provide a similar return on investment for licensed producers and pharmaceutical companies. Historically, clinical trials on CBMPs were funded privately, which may be associated with potential reporting biases [ 19 ].

RCTs are possible with CBMPs; however, the above issues present legitimate challenges. In many chronic diseases there is a need for novel therapeutics and CBMPs are therefore being utilised based on best available evidence. Due to the challenges in developing CBMPs through a traditional drug development pipeline, the exploration of its utility should not be limited to traditional methods. It is important that we capture a suite of real-world evidence (RWE) to inform prescribing guidelines, regulations, and clinical trials. By leaning on RWE there is an opportunity to improve the quality and design of RCTs and clinical evidence in general, via a top-down approach [ 20 ].

Real World Evidence

RWE is defined as evidence derived from health data sourced from non-interventional studies, registries, electronic health records and insurance data as opposed to the highly controlled setting of RCTs [ 21 ]. There is an abundance of this unstructured data, however, the necessary frameworks and governance are needed for the application of this data [ 22 ]. It is currently used extensively to monitor post-approval pharmacovigilence [ 23 ]. There is clear evidence of benefit in using population-based data to detect safety events associated with specific medications to implement restrictions to reduce harm [ 21 ].

Consistent use of RWE to aid regulatory decision making is yet to be normalised, but the promise is apparent [ 21 ]. Recently, regulator-supported initiatives have highlighted the desire to incorporate RWE into licensing and guidelines, developing a framework which can incorporate its insights into decisions regarding safety and effectiveness [ 21 , 22 ]. It is important that studies standardise their methodology according to those set out by regulatory authorities to ensure research has the greatest impact [ 21 , 22 ]. Moreover, they should seek to directly address questions set out by governing bodies as areas where there is insufficient research [ 24 ].

Types of Real-World Evidence for Medical Cannabis

NHS England and NHS improvement published a review on the barriers to accessing CBMPs in the UK [ 3 ]. Their recommendations included the need for the collection of structured data, and the development of methods to further support the generation of new evidence, for patients who cannot enrol onto relevant RCTs.

RWE is already being incorporated into the scientific literature on cannabis (Table ​ (Table1). 1 ). Early examples utilised state-level records to examine the effects of cannabis laws on opioid misuse. Subsequently there have been examples of online and self-administered survey tools analysing national outcomes. More recently there has been a focus on collecting evidence from clinical registries and databases with evidence generated from patient-reported outcome measures and long-term pharmacovigilance.

Examples of Real World Evidence Generation for Cannabis-Based Medicinal Products

Comparison of Real-World Evidence and Controlled Clinical Trials

Between these study designs it is important to be aware of potential divergence in reported outcomes. RWE has broader inclusion criteria, accounting for factors like non-standard dosing, and is not limited by scope of disease, thereby improving ecological validity [ 25 ]. However, some studies have concluded there is little difference between results obtained via RCTs and observational studies [ 26 ]. RWE typically has longer patient follow-up and may consequently capture rare but important adverse effects that are not detected within RCTs. Pharmacovigilance is therefore widely accepted as one of the most important roles of RWE.

RWE can bring further clarity on questions that remain unanswered in RCTs. A recent study utilised anonymised surveys of patients with fibromyalgia who consumed cannabis flower [ 27 ]. In addition to reporting positive outcomes on depression and pain the study also reported negative aspects of cannabis consumption, for example driving under the influence (72% of patients) [ 27 ]. These are findings which are unlikely to be reported by patients in controlled clinical trials for fear of repercussions, or strict inclusion criteria. It can also be useful in collecting data in rare conditions whereby recruitment to RCTs can be limited by the need for defined trial sites.

RWE can improve the efficiency of clinical trials by generating hypotheses, refining eligibility criteria, and exploring drug development tools. Registries can be used to form an infrastructure to conduct a clinical trial, lowering costs whilst maintaining high evidence quality [ 28 ]. In supplemented single arm trials the controls are derived from RWE-data sets, providing the opportunity for patient centric study designs. RCTs can also be augmented with real-world data to increase the size of the control group to increase the power of the study. These study designs are particularly useful for rare diseases where participant recruitment is challenging [ 29 ].

Limitations of Real-World Evidence

RWE, however, does have limits to its utility. There is variation in the quality and provenance of the data stored in electronic medical records [ 5 ]. Furthermore, insurance records typically use coding specific for reimbursement purposes and may not provide all clinically relevant information. RWE can require complex statistical expertise to deduce valid conclusions.

Another limitation is the lack of randomisation, controlled variables and internal validity. This can make it more difficult to derive causative mechanisms behind clinical outcomes. However, this is also one of the strengths of these studies, allowing for generalisability to true clinical practice [ 22 ]. Treatment assignment based on the physician as opposed to randomisation, creates selection bias and more specifically stigma biases. RCTs, therefore, are still necessary to establish a strong causal relationship between medication and outcomes [ 30 ].

CBMPs are a complex range of pharmaceuticals which pose challenges to traditional pathways of drug development and translation. Development of CBMPs requires novel approaches of evidence collection to address these challenges. RWE can be used in conjunction or as an extension to RCTs to both broaden and streamline the process of evidence generation. Currently, there is an abundance of potential data, however, it is important the right tools and analysis are utilised to unlock potential insights from these.

Acknowledgements

Abbreviations, author contributions.

RB and SE prepared the manuscript. OS, NM, DC, BP, MS read and approved the final manuscript.

Availability of Data and Materials

Declarations.

SE: Sapphire Medical Clinics. DC: Medical Lead Centre for Medicinal Cannabis. BP: Chief Scientific Officer at Emmac Life Sciences. MHS: Sapphire Medical Clinics Managing Director and Research lead at Emmac Life Sciences.

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Volunteers needed for paid cannabis research studies

By Hub staff report

Healthy volunteers are needed to take part in four Johns Hopkins research studies involving cannabis, one of which involves tobacco and cannabis. Principal investigator for all the studies is Ryan Vandrey, PhD. Brief descriptions of the studies, the amount of compensation, and contact phone numbers follow:

People age 18–55 who are current tobacco users and have a history of occasionally using cannabis (marijuana) . Participants will be paid up to $1,730 for study completion. Study involves smoking cannabis and also smoking a tobacco cigarette or vaping with an e-cigarette over seven experimental sessions. Call 410-550-5254 for more information. Protocol #: IRB00220975. Approved Jan. 15, 2020.

Volunteers age 18-50 who have a history of using cannabis (marijuana) but have not used any in the past month . Participants will be paid up to $1,380 for study completion. Study involves consuming a brownie containing THC and/or CBD and other drugs which people are commonly prescribed or get over the counter. For more information, call 410-550-6989. Protocol #: IRB00207237. Approved March 3, 2020.

Volunteers age 18–55 who have a history of occasionally using cannabis (marijuana) . Participants will be paid up to $3,230 for study completion. Study involves vaping substances found in cannabis (such as THC) in nine separate experimental sessions, each lasting about seven hours. There is also a separate screening visit lasting about three hours to determine eligibility. Call 410-550-5254 for more information. Protocol #: IRB00182689. Approved May 26, 2020.

Volunteers age 18–55 who have a history of occasionally using cannabis (marijuana) . Participants will be paid up to $3,230 for study completion (some participants will be invited to complete a 10th session that would increase earnings to $3,530). Study involves vaping substances found in cannabis (such as THC) in nine separate experimental sessions. There is also a separate screening visit lasting about three hours to determine eligibility. For more information, call 410-550-5254. Protocol #: IRB00085652. Approved June 9, 2020.

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• Published: 12 August 2016

Why the US decision to expand marijuana supply for research matters

• Ramin Skibba  

Nature ( 2016 ) Cite this article

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• Drug discovery
• Health care
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Policy change could accelerate development of treatments derived from the drug.

Scientists and medical researchers in the United States have been studying the health benefits and risks of marijuana for decades. But despite the increasing availability of legal marijuana, scientists have been forced to obtain the drug from a single source — the University of Mississippi in Oxford, which grows pot for research on a campus farm under a contract with the National Institute on Drug Abuse (NIDA).

Now, the university’s monopoly is coming to an end. In an unexpected move, the US Drug Enforcement Administration (DEA) announced on 11 August that it will allow any institution to apply for permission to grow marijuana for research. Nature explains how the policy could transform the study of marijuana.

Why do researchers want to study pot — and how do they get it?

Researchers have been extracting cannabinoids — chemical compounds found in cannabis — and developing strains of varying strength to test whether they could alleviate chronic pain and treat or mitigate the effects of ailments such as seizures and other neurological disorders.

But because the federal government still classifies marijuana as a drug with no medical use, scientists have faced a time-consuming process to obtain pot for research from NIDA. Those who conduct clinical research also need to seek approval from the Food and Drug Administration.

Why does relying on a single grower limit research?

Approved medical-marijuana consumers may buy pot from dispensaries in more than half the country, and recreational marijuana use is permitted in a few states. But researchers are limited to the handful of strains grown by the University of Mississippi farm.

Some of the Mississippi-grown strains have lower concentrations of tetrahydrocannabinol , the active ingredient in pot, than the marijuana available to the public — making studies that use these varieties of the drug less applicable to typical consumers.

Why is the US government increasing the number of approved growers?

The DEA says that the change is motivated by a high demand from scientists and a desire to encourage research on pot. “Additional growers mean additional varieties will be available to address the diversity of research needs,” said NIDA director Nora Volkow in a statement.

For decades, research supported by NIDA focused on harmful health effects and the risks of marijuana use. But in recent years, research has uncovered possible health benefits as well. These include the drug's anti-inflammatory effects and its therapeutic role in treating epilepsy and other neuropsychiatric disorders.

“It’s an incredible pleasure to see the DEA let the science speak for itself,” says Rick Doblin, director of the Multidisciplinary Association for Psychedelic Studies, a non-profit organization in Santa Cruz, California, that funds research into these drugs.

How will the new rules work?

Anyone who has a research protocol approved through the Department of Health and Human Services can apply to become a federally authorized marijuana grower, says Rusty Payne, a spokesperson for the DEA in Washington DC. “We’re expecting a lot of applications,” he adds.

As more growers pop up in other places, researchers will no longer have to go through NIDA to obtain the marijuana and cannabinoid extracts that they require for their work. The hope is that this will facilitate more-thorough clinical studies and make it possible for researchers to identify the most effective strains for particular treatments.

Scientists are excited about the policy announcement. “NIDA monopoly finally gone,” tweeted Sunil Aggarwal, a New York City-based physician who studies cannabis use in hospice healthcare. “1 big brick in federal govt wall around cannabis being knocked out,” he added .

Will this decision affect the push to legalize marijuana across the country?

The policy change could help to remove a key obstacle to the legalization of marijuana. Research was previously stalled by small trials and experiments, for example, because researchers were limited to testing drugs with only a handful of people. Once drugs, including cannibinoids, can be administered to larger groups of people, and their effectiveness and safety confirmed, medicinal treatments of marijuana could become more widely approved and accepted.

“Widespread approval of medical marijuana in many states may have persuaded the federal agency in their decision-making process,” says Trevor Castor, head of Aphios, a company in Woburn, Massachusetts that has NIDA funding to develop a process for manufacturing cannabinoids. Castor thinks that national legalization will follow. “But,” he says, “I’m not sure when.”

One obstacle for advocates of legalization is opposition by some corners of the federal government. On 11 August, the DEA reaffirmed its classification of cannabis as a dangerous substance, which puts the drug in the same regulatory category as LSD, meth and heroin.

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NIDA Research on Cannabis and Cannabinoids

What kinds of marijuana research does nida fund.

As part of its mandate to study drug abuse and addiction and other health effects of both legal and illegal drugs, NIDA funds a wide range of research on marijuana (cannabis); its main psychotropic ingredient, delta-9-tetrahydrocannabinol (THC); and chemicals related to THC (cannabinoids), including:

• Patterns and trends in marijuana use and attitudes, particularly among adolescents, including THC vaping
• Short- and medium-term effects of THC on the brain and behavior; driving under the influence of cannabis; and genetic, epigenetic, and environmental factors that mediate marijuana’s effects
• Long-term effects of prenatal and adolescent cannabis exposure on brain development
• Development and impact assessment of prevention programs on marijuana use
• Screening and brief assessment for cannabis use disorder
• Medications, mHealth, and behavioral treatments for cannabis use disorder
• Function of the brain’s endocannabinoid system, including its role in pain, mental illness, and HIV
• Potential therapeutic uses of THC and other cannabinoids in treatment of pain, HIV, addiction, and other health conditions
• Social, behavioral, and public health and safety impacts of policy changes related to marijuana (i.e., “medical marijuana” and recreational legalization)

Does NIH permit or fund studies on therapeutic benefits of marijuana or its constituent chemicals?

Yes. Research suggests that THC and other cannabinoids, may have potential in the treatment of pain, nausea, epilepsy, obesity, wasting disease, addiction, autoimmune disorders, and other conditions. NIDA has provided and continues to provide funding for research related to therapeutic uses of cannabinoids as it pertains to its mission, including studies on the use of THC and cannabidiol (CBD), another chemical constituent of marijuana, for the treatment of pain (as an alternative to opioid pain relievers), addiction, and other disorders. Research on therapeutic uses of marijuana or of specific chemicals in the marijuana plant for other diseases and conditions is supported by other components of the National Institute of Health (NIH) as is appropriate to their mission.  For a complete listing of all projects funded by NIH examining the potential therapeutic benefits of cannabinoids, see the Therapeutic Cannabinoid Research category in the NIH RePORT database .

The vast majority of research proposals received and funded by NIH on therapeutic benefits of cannabinoids have examined individual cannabinoid chemicals or, in a few cases, marijuana leaves delivered through some means other than smoking. Various factors make smoked marijuana less therapeutically promising than cannabinoids medications delivered through alternative routes of administration, including the potential harmful effects on the lungs and the risk for addiction. In addition, marijuana leaves contain numerous poorly understood chemicals in addition to THC and CBD. It is difficult to standardize dosages of a smoked plant with highly variable cannabinoid concentrations (see NIDA’s DrugFacts, Marijuana as Medicine ). A few medications derived from THC, however, are now approved by the U.S. Food and Drug Administration for relieving nausea associated with cancer chemotherapy and stimulating appetite in patients with wasting syndrome that often accompanies AIDS.

Research proposals submitted to any NIH Institute of Center (IC) to study therapeutic benefits of marijuana or one of its ingredients must meet the same accepted standards of scientific design as any other proposal and, on the basis of peer review, should meet public health significance and IC priorities to be competitive with other applications that qualify for funding.

Does NIDA have an official stand on legalization or decriminalization of marijuana for either recreational or therapeutic use?

No. NIDA is a scientific, not a policy-making agency. The same is true for the NIH as a whole. NIDA’s role is to conduct and support scientific research on drugs and drug abuse and to advise the public and policy-makers, such as Congress, the White House Office of the National Drug Control Policy , and the U.S. Drug Enforcement Administration on the results of that research—with the goal of ensuring that the nation’s drug policies are informed by science.That said, NIDA does closely watch legislative changes both nationally and at the state level and supports research that studies how changing drug policies—for instance laws around recreational or therapeutic use of marijuana—affect rates of substance use and related public health issues.

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MEDICATION Our medical team, composed of addiction psychiatrists and trained nurse practitioners may provide medication for you to take regularly over the course of the study. In addition, they may meet with you regularly to assess your safety and well-being, your physical and mental health, and your progress in cutting back on marijuana use.

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Got tinnitus a device that tickles the tongue helps this musician find relief.

Allison Aubrey

After using the Lenire device for an hour each day for 12 weeks, Victoria Banks says her tinnitus is "barely noticeable." David Petrelli/Victoria Banks hide caption

After using the Lenire device for an hour each day for 12 weeks, Victoria Banks says her tinnitus is "barely noticeable."

Imagine if every moment is filled with a high-pitched buzz or ring that you can't turn off.

More than 25 million adults in the U.S., have a condition called tinnitus, according to the American Tinnitus Association. It can be stressful, even panic-inducing and difficult to manage. Dozens of factors can contribute to the onset of tinnitus, including hearing loss, exposure to loud noise or a viral illness.

There's no cure, but there are a range of strategies to reduce the symptoms and make it less bothersome, including hearing aids, mindfulness therapy , and one newer option – a device approved by the FDA to treat tinnitus using electrical stimulation of the tongue.

The device has helped Victoria Banks, a singer and songwriter in Nashville, Tenn., who developed tinnitus about three years ago.

"The noise in my head felt like a bunch of cicadas," Banks says. "It was terrifying." The buzz made it difficult for her to sing and listen to music. "It can be absolutely debilitating," she says.

Shots - Health News

Tinnitus bothers millions of americans. here's how to turn down the noise.

Banks tried taking dietary supplements , but those didn't help. She also stepped up exercise, but that didn't bring relief either. Then she read about a device called Lenire, which was approved by the FDA in March 2023. It includes a plastic mouthpiece with stainless steel electrodes that electrically stimulate the tongue. It is the first device of its kind to be approved for tinnitus.

"This had worked for other people, and I thought I'm willing to try anything at this point," Banks recalls.

She sought out audiologist Brian Fligor, who treats severe cases of tinnitus in the Boston area. Fligor was impressed by the results of a clinical trial that found 84% of participants who tried Lenire experienced a significant reduction in symptoms. He became one of the first providers in the U.S. to use the device with his patients. Fligor also served on an advisory panel assembled by the company who developed it.

"A good candidate for this device is somebody who's had tinnitus for at least three months," Fligor says, emphasizing that people should be evaluated first to make sure there's not an underlying medical issue.

Tinnitus often accompanies hearing loss, but Victoria Banks' hearing was fine and she had no other medical issue, so she was a good candidate.

Banks used the device for an hour each day for 12 weeks. During the hour-long sessions, the electrical stimulation "tickles" the tongue, she says. In addition, the device includes a set of headphones that play a series of tones and ocean-wave sounds.

The device works, in part, by shifting the brain's attention away from the buzz. We're wired to focus on important information coming into our brains, Fligor says. Think of it as a spotlight at a show pointed at the most important thing on the stage. "When you have tinnitus and you're frustrated or angry or scared by it, that spotlight gets really strong and focused on the tinnitus," Fligor says.

"It's the combination of what you're feeling through the nerves in your tongue and what you're hearing through your ears happening in synchrony that causes the spotlight in your brain to not be so stuck on the tinnitus," Fligor explains.

A clinical trial found 84% of people who used the device experienced a significant reduction in symptoms. Brian Fligor hide caption

A clinical trial found 84% of people who used the device experienced a significant reduction in symptoms.

"It unsticks your spotlight" and helps desensitize people to the perceived noise that their tinnitus creates, he says.

Banks says the ringing in her ears did not completely disappear, but now it's barely noticeable on most days.

"It's kind of like if I lived near a waterfall and the waterfall was constantly going," she says. Over time, the waterfall sound fades out of consciousness.

"My brain is now focusing on other things," and the buzz is no longer so distracting. She's back to listening to music, writing music, and performing music." I'm doing all of those things," she says.

When the buzz comes back into focus, Banks says a refresher session with the device helps.

A clinical trial found that 84% of people who tried Lenire , saw significant improvements in their condition. To measure changes, the participants took a questionnaire that asked them to rate how much tinnitus was impacting their sleep, sense of control, feelings of well-being and quality of life. After 12 weeks of using the device, participants improved by an average of 14 points.

"Where this device fits into the big picture, is that it's not a cure-all, but it's quickly become my go-to," for people who do not respond to other ways of managing tinnitus, Fligor says.

One down-side is the cost. Banks paid about $4,000 for the Lenire device, and insurance doesn't cover it. She put the expense on her credit card and paid it off gradually.

Fligor hopes that as the evidence of its effectiveness accumulates, insurers will begin to cover it. Despite the cost, more than 80% of participants in the clinical trial said they would recommend the device to a friend with tinnitus.

But, it's unclear how long the benefits last. Clinical trials have only evaluated Lenire over a 1-year period. "How durable are the effects? We don't really know yet," says audiologist Marc Fagelson, the scientific advisory committee chair of the American Tinnitus Association. He says research is promising but there's still more to learn.

Fagelson says the first step he takes with his patients is an evaluation for hearing loss. Research shows that hearing aids can be an effective treatment for tinnitus among people who have both tinnitus and hearing loss, which is much more common among older adults. An estimated one-third of adults 65 years of age and older who have hearing loss, also have tinnitus.

"We do see a lot of patients, even with very mild loss, who benefit from hearing aids," Fagelson says, but in his experience it's about 50-50 in terms of improving tinnitus. Often, he says people with tinnitus need to explore options beyond hearing aids.

Bruce Freeman , a scientist at the University of Pittsburgh Medical Center, says he's benefitted from both hearing aids and Lenire. He was fitted for the device in Ireland where it was developed, before it was available in the U.S.

Freeman agrees that the ringing never truly disappears, but the device has helped him manage the condition. He describes the sounds that play through the device headphones as very calming and "almost hypnotic" and combined with the tongue vibration, it's helped desensitize him to the ring.

Freeman – who is a research scientist – says he's impressed with the results of research, including a study published in Nature, Scientific Reports that points to significant improvements among clinical trial participants with tinnitus.

Freeman experienced a return of his symptoms when he stopped using the device. "Without it the tinnitus got worse," he says. Then, when he resumed use, it improved.

Freeman believes his long-term exposure to noisy instruments in his research laboratory may have played a role in his condition, and also a neck injury from a bicycle accident that fractured his vertebra. "All of those things converged," he says.

Freeman has developed several habits that help keep the high-pitched ring out of his consciousness and maintain good health. "One thing that does wonders is swimming," he says, pointing to the swooshing sound of water in his ears. "That's a form of mindfulness," he explains.

When it comes to the ring of tinnitus, "it comes and goes," Freeman says. For now, it has subsided into the background, he told me with a sense of relief. "The last two years have been great," he says – a combination of the device, hearing aids and the mindfulness that comes from a swim.

This story was edited by Jane Greenhalgh

• ringing in ears
• hearing loss