User login
Over-the-Counter Hearing Aids as Effective as Traditional Models
Nearly 2 years ago, over-the-counter (OTC) hearing aids became available without a prescription. Audiologists and consumers have doubted their effectiveness, but OTC hearing aids can be as good as — and sometimes better — than traditional aids at half the cost.
A new study published in JAMA Otolaryngology–Head & Neck Surgery showed OTC hearing aids to be as or more effective in treating mild to moderate hearing loss.
“This means consumers with mild to moderate hearing loss can now access cost-effective devices without compromising on long-term benefits,” said De Wet Swanepoel, PhD, professor in the Department of Speech-Language Pathology and Audiology at the University of Pretoria in South Africa, and an author of the study.
Approximately 30% of people over the age of 70 who could benefit from hearing aids actually use them. In 2022, the US Food and Drug Administration (FDA) allowed the sale of nonprescription devices. But a year later, just 2% of people with hearing difficulty had purchased OTC hearing aids. Impaired hearing can increase the risk of developing dementia and decrease quality of life.
Dr. Swanepoel and his colleagues enrolled 44 individuals in the comparative effectiveness study, which was an extension of an initial randomized control trial lasting 6 weeks. Participants were tracked over an 8-month period, with about half using self-fitted OTC devices and the remaining with audiologist-fitted models. On the basis of users’ self-reported surveys, the results showed no clinically meaningful difference in effectiveness. The OTC hearing aids showed better satisfaction scores among users.
The typical pair of audiologist-fitted hearing aids costs $2000. OTC hearing aids, including the Lexi Lumen model used in the latest study and available in the United States, cost around $799.
“The cost savings combined with the effective performance of self-fit hearing aids make them a promising option for individuals with mild to moderate hearing loss,” Dr. Swanepoel said.
But many audiologists have reported they do not believe the nonprescription devices would provide the same benefit as a hearing aid provided by specialists, according to one survey in 2023.
OTC hearing aids may change the role of the primary care clinician, who may instead of referring patients to an audiologist, suggest a nonprescription version. They may also field questions from patients on which types are better, which Sharon Horesh Bergquist, MD, an internal medicine physician at Emory University in Atlanta, said she is already doing.
“Primary care physicians already evaluate patients with hearing loss to identify underlying causes and provide referrals to audiologists or ear, nose, and throat specialists; with the availability of OTC hearing aids, they can further support patients by informing them about these accessible options and help them understand when OTC aids may be appropriate,” Dr. Bergquist said.
When selecting a model, Dr. Bergquist recommends patients try them before buying. Certain models permit returns, but she advises patients to check the terms as not all models are the same.
“By removing the requirement to see an audiologist or ear, nose, and throat specialist, OTC hearing aids can increase use among individuals who might otherwise forgo them without eliminating the need for professional care,” Dr. Bergquist said.
She does refer some patients to visit an audiologist first to understand their type and cause of hearing impairment, which can help users select the best OTC model for them.
The study received funding from the hearX Pty Ltd Group and the National Institutes of Health. Various authors reported receiving personal fees from the hearX Group and Care Research Manchester Biomedical Research Centre.
A version of this article first appeared on Medscape.com.
Nearly 2 years ago, over-the-counter (OTC) hearing aids became available without a prescription. Audiologists and consumers have doubted their effectiveness, but OTC hearing aids can be as good as — and sometimes better — than traditional aids at half the cost.
A new study published in JAMA Otolaryngology–Head & Neck Surgery showed OTC hearing aids to be as or more effective in treating mild to moderate hearing loss.
“This means consumers with mild to moderate hearing loss can now access cost-effective devices without compromising on long-term benefits,” said De Wet Swanepoel, PhD, professor in the Department of Speech-Language Pathology and Audiology at the University of Pretoria in South Africa, and an author of the study.
Approximately 30% of people over the age of 70 who could benefit from hearing aids actually use them. In 2022, the US Food and Drug Administration (FDA) allowed the sale of nonprescription devices. But a year later, just 2% of people with hearing difficulty had purchased OTC hearing aids. Impaired hearing can increase the risk of developing dementia and decrease quality of life.
Dr. Swanepoel and his colleagues enrolled 44 individuals in the comparative effectiveness study, which was an extension of an initial randomized control trial lasting 6 weeks. Participants were tracked over an 8-month period, with about half using self-fitted OTC devices and the remaining with audiologist-fitted models. On the basis of users’ self-reported surveys, the results showed no clinically meaningful difference in effectiveness. The OTC hearing aids showed better satisfaction scores among users.
The typical pair of audiologist-fitted hearing aids costs $2000. OTC hearing aids, including the Lexi Lumen model used in the latest study and available in the United States, cost around $799.
“The cost savings combined with the effective performance of self-fit hearing aids make them a promising option for individuals with mild to moderate hearing loss,” Dr. Swanepoel said.
But many audiologists have reported they do not believe the nonprescription devices would provide the same benefit as a hearing aid provided by specialists, according to one survey in 2023.
OTC hearing aids may change the role of the primary care clinician, who may instead of referring patients to an audiologist, suggest a nonprescription version. They may also field questions from patients on which types are better, which Sharon Horesh Bergquist, MD, an internal medicine physician at Emory University in Atlanta, said she is already doing.
“Primary care physicians already evaluate patients with hearing loss to identify underlying causes and provide referrals to audiologists or ear, nose, and throat specialists; with the availability of OTC hearing aids, they can further support patients by informing them about these accessible options and help them understand when OTC aids may be appropriate,” Dr. Bergquist said.
When selecting a model, Dr. Bergquist recommends patients try them before buying. Certain models permit returns, but she advises patients to check the terms as not all models are the same.
“By removing the requirement to see an audiologist or ear, nose, and throat specialist, OTC hearing aids can increase use among individuals who might otherwise forgo them without eliminating the need for professional care,” Dr. Bergquist said.
She does refer some patients to visit an audiologist first to understand their type and cause of hearing impairment, which can help users select the best OTC model for them.
The study received funding from the hearX Pty Ltd Group and the National Institutes of Health. Various authors reported receiving personal fees from the hearX Group and Care Research Manchester Biomedical Research Centre.
A version of this article first appeared on Medscape.com.
Nearly 2 years ago, over-the-counter (OTC) hearing aids became available without a prescription. Audiologists and consumers have doubted their effectiveness, but OTC hearing aids can be as good as — and sometimes better — than traditional aids at half the cost.
A new study published in JAMA Otolaryngology–Head & Neck Surgery showed OTC hearing aids to be as or more effective in treating mild to moderate hearing loss.
“This means consumers with mild to moderate hearing loss can now access cost-effective devices without compromising on long-term benefits,” said De Wet Swanepoel, PhD, professor in the Department of Speech-Language Pathology and Audiology at the University of Pretoria in South Africa, and an author of the study.
Approximately 30% of people over the age of 70 who could benefit from hearing aids actually use them. In 2022, the US Food and Drug Administration (FDA) allowed the sale of nonprescription devices. But a year later, just 2% of people with hearing difficulty had purchased OTC hearing aids. Impaired hearing can increase the risk of developing dementia and decrease quality of life.
Dr. Swanepoel and his colleagues enrolled 44 individuals in the comparative effectiveness study, which was an extension of an initial randomized control trial lasting 6 weeks. Participants were tracked over an 8-month period, with about half using self-fitted OTC devices and the remaining with audiologist-fitted models. On the basis of users’ self-reported surveys, the results showed no clinically meaningful difference in effectiveness. The OTC hearing aids showed better satisfaction scores among users.
The typical pair of audiologist-fitted hearing aids costs $2000. OTC hearing aids, including the Lexi Lumen model used in the latest study and available in the United States, cost around $799.
“The cost savings combined with the effective performance of self-fit hearing aids make them a promising option for individuals with mild to moderate hearing loss,” Dr. Swanepoel said.
But many audiologists have reported they do not believe the nonprescription devices would provide the same benefit as a hearing aid provided by specialists, according to one survey in 2023.
OTC hearing aids may change the role of the primary care clinician, who may instead of referring patients to an audiologist, suggest a nonprescription version. They may also field questions from patients on which types are better, which Sharon Horesh Bergquist, MD, an internal medicine physician at Emory University in Atlanta, said she is already doing.
“Primary care physicians already evaluate patients with hearing loss to identify underlying causes and provide referrals to audiologists or ear, nose, and throat specialists; with the availability of OTC hearing aids, they can further support patients by informing them about these accessible options and help them understand when OTC aids may be appropriate,” Dr. Bergquist said.
When selecting a model, Dr. Bergquist recommends patients try them before buying. Certain models permit returns, but she advises patients to check the terms as not all models are the same.
“By removing the requirement to see an audiologist or ear, nose, and throat specialist, OTC hearing aids can increase use among individuals who might otherwise forgo them without eliminating the need for professional care,” Dr. Bergquist said.
She does refer some patients to visit an audiologist first to understand their type and cause of hearing impairment, which can help users select the best OTC model for them.
The study received funding from the hearX Pty Ltd Group and the National Institutes of Health. Various authors reported receiving personal fees from the hearX Group and Care Research Manchester Biomedical Research Centre.
A version of this article first appeared on Medscape.com.
FROM JAMA OTOLARYNGOLOGY–HEAD & NECK SURGERY
US Researchers Call for Robust Studies Into Dequalinium, a Bacterial Vaginosis Therapy Common in Europe
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Sarcopenia With Obesity Increases Risk for Death
TOPLINE:
Patients with sarcopenic obesity (SO) are at a greater risk for earlier death, but screening for muscle function could offer an opportunity for intervention.
METHODOLOGY:
- The proportion of older adults living with high body fat and/or low muscle function and mass has risen in recent years, but sarcopenia and SO are undiagnosed conditions.
- Researchers evaluated 5888 individuals who participated in a population-based cohort study in the Netherlands: Participants were largely of European descent (98%); the mean age of participants was 69.5 years, and 56.8% were female.
- Participants were included if they had available measurements of handgrip strength and had received a dual-energy x-ray absorptiometry scan.
- Sarcopenia was defined by researchers in JAMA Network Open as having low handgrip strength and was confirmed with a low appendicular skeletal muscle mass index; SO was defined as a body mass index (BMI) over 27, having low handgrip strength, a high fat percentage, and/or a low appendicular skeletal muscle index, which were defined as altered body composition (BC).
TAKEAWAY:
- Participants with SO and one BC component were at a higher risk for all-cause mortality (hazard ratio [HR], 1.94; 95% CI, 1.60-2.33).
- Participants with SO and both components of BC had almost three times the risk for mortality as those without (HR, 2.84; 95% CI, 1.97-4.11).
IN PRACTICE:
“These results suggest that screening for SO might be implemented in primary care. In addition, early nonpharmacologic interventions, such as nutrition and exercise training, should be included to delay the onset of and to treat sarcopenia, especially SO,” the researchers wrote.
SOURCE:
Yves Boirie, MD, PhD, of the Human Nutrition Unit at Université Clermont Auvergne in Clermont-Ferrand, France, is the corresponding author for this study. The study was funded by the Netherlands Organisation for Health Research and Development, the French National Research Agency, and the European Union’s Horizon 2020 research and innovation program, among others.
LIMITATIONS:
The researchers also did not consider specific causes of death. Because the most participants had European ancestry, the results cannot be generalized.
DISCLOSURES:
Various authors report receiving grants from the Agence Nationale de la Recherche and Agencia Estatal de Investigación. Other authors report being members of advisory board panels for Pfizer, Eli Lilly, Novo Nordisk, and Nutricia Research.
A version of this article appeared on Medscape.com.
TOPLINE:
Patients with sarcopenic obesity (SO) are at a greater risk for earlier death, but screening for muscle function could offer an opportunity for intervention.
METHODOLOGY:
- The proportion of older adults living with high body fat and/or low muscle function and mass has risen in recent years, but sarcopenia and SO are undiagnosed conditions.
- Researchers evaluated 5888 individuals who participated in a population-based cohort study in the Netherlands: Participants were largely of European descent (98%); the mean age of participants was 69.5 years, and 56.8% were female.
- Participants were included if they had available measurements of handgrip strength and had received a dual-energy x-ray absorptiometry scan.
- Sarcopenia was defined by researchers in JAMA Network Open as having low handgrip strength and was confirmed with a low appendicular skeletal muscle mass index; SO was defined as a body mass index (BMI) over 27, having low handgrip strength, a high fat percentage, and/or a low appendicular skeletal muscle index, which were defined as altered body composition (BC).
TAKEAWAY:
- Participants with SO and one BC component were at a higher risk for all-cause mortality (hazard ratio [HR], 1.94; 95% CI, 1.60-2.33).
- Participants with SO and both components of BC had almost three times the risk for mortality as those without (HR, 2.84; 95% CI, 1.97-4.11).
IN PRACTICE:
“These results suggest that screening for SO might be implemented in primary care. In addition, early nonpharmacologic interventions, such as nutrition and exercise training, should be included to delay the onset of and to treat sarcopenia, especially SO,” the researchers wrote.
SOURCE:
Yves Boirie, MD, PhD, of the Human Nutrition Unit at Université Clermont Auvergne in Clermont-Ferrand, France, is the corresponding author for this study. The study was funded by the Netherlands Organisation for Health Research and Development, the French National Research Agency, and the European Union’s Horizon 2020 research and innovation program, among others.
LIMITATIONS:
The researchers also did not consider specific causes of death. Because the most participants had European ancestry, the results cannot be generalized.
DISCLOSURES:
Various authors report receiving grants from the Agence Nationale de la Recherche and Agencia Estatal de Investigación. Other authors report being members of advisory board panels for Pfizer, Eli Lilly, Novo Nordisk, and Nutricia Research.
A version of this article appeared on Medscape.com.
TOPLINE:
Patients with sarcopenic obesity (SO) are at a greater risk for earlier death, but screening for muscle function could offer an opportunity for intervention.
METHODOLOGY:
- The proportion of older adults living with high body fat and/or low muscle function and mass has risen in recent years, but sarcopenia and SO are undiagnosed conditions.
- Researchers evaluated 5888 individuals who participated in a population-based cohort study in the Netherlands: Participants were largely of European descent (98%); the mean age of participants was 69.5 years, and 56.8% were female.
- Participants were included if they had available measurements of handgrip strength and had received a dual-energy x-ray absorptiometry scan.
- Sarcopenia was defined by researchers in JAMA Network Open as having low handgrip strength and was confirmed with a low appendicular skeletal muscle mass index; SO was defined as a body mass index (BMI) over 27, having low handgrip strength, a high fat percentage, and/or a low appendicular skeletal muscle index, which were defined as altered body composition (BC).
TAKEAWAY:
- Participants with SO and one BC component were at a higher risk for all-cause mortality (hazard ratio [HR], 1.94; 95% CI, 1.60-2.33).
- Participants with SO and both components of BC had almost three times the risk for mortality as those without (HR, 2.84; 95% CI, 1.97-4.11).
IN PRACTICE:
“These results suggest that screening for SO might be implemented in primary care. In addition, early nonpharmacologic interventions, such as nutrition and exercise training, should be included to delay the onset of and to treat sarcopenia, especially SO,” the researchers wrote.
SOURCE:
Yves Boirie, MD, PhD, of the Human Nutrition Unit at Université Clermont Auvergne in Clermont-Ferrand, France, is the corresponding author for this study. The study was funded by the Netherlands Organisation for Health Research and Development, the French National Research Agency, and the European Union’s Horizon 2020 research and innovation program, among others.
LIMITATIONS:
The researchers also did not consider specific causes of death. Because the most participants had European ancestry, the results cannot be generalized.
DISCLOSURES:
Various authors report receiving grants from the Agence Nationale de la Recherche and Agencia Estatal de Investigación. Other authors report being members of advisory board panels for Pfizer, Eli Lilly, Novo Nordisk, and Nutricia Research.
A version of this article appeared on Medscape.com.