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OtoRhinoLaryngology by Sfakianakis G.Alexandros Sfakianakis G.Alexandros,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,tel : 00302841026182,00306932607174
Publication date: Available online 25 August 2018
Source: Gait & Posture
Author(s): Feng Yang, Patrick Cereceres, Mu Qiao
Treadmill-based gait-slip training shows to be effective in reducing the risk of slip-related falls. In previous relevant studies, the number of repeated slip perturbations ranged from 12 to 30.
It is unclear if a reduced number of treadmill-slips can still yield adaptive strategies to lower the likelihood of falls after a slip over ground. This study examined if eight repeated slips on a treadmill reduced the risk of falls among young adults when they were exposed to a novel overground slip.
Forty-three healthy young adults were randomized into either training or control group. The training group underwent an 8-slip perturbation training procedure on a treadmill while the control group received the same number of normal walking trials on the same treadmill. Following the training, both groups were exposed to an unrehearsed slip during overground walking. Their body’s reactions to the novel overground slip were collected by a motion capture system.
The training group exhibited significantly better reactions to the slip than did the control group, evidenced by the lower fall proportion and improved dynamic stability at recovery foot touchdown during the overground slip. No improvement in dynamic stability was detected in the training group at the slipping foot touchdown and recovery foot liftoff.
The results suggested that the shortened perturbation training program may be efficacious in improving responses to a novel overground slip but may not be as effective as protocols using greater number of slips. This study could provide guidance for selecting the number of slips for future perturbation-based training protocols.
Publication date: Available online 25 August 2018
Source: Gait & Posture
Author(s): Sho Nakakubo, Takehiko Doi, Hyuma Makizako, Kota Tsutsumimoto, Ryo Hotta, Satoshi Kurita, Minji Kim, Takao Suzuki, Hiroyuki Shimada
Walk ratio (WR), calculated by dividing step length by cadence, can be used to represent the gait characteristics of human beings to maintain their gait speed.
Research question: The aim of this study was to examine whether WR could distinguish fallers from community-dwelling elderly people.
We recruited 9,205 elderly people (mean age: 73.7 ± 5.6 years, 4,218 men and 4,987 women) from the National Center for Geriatrics and Gerontology – Study of Geriatric Syndromes. Fall history was assessed by face-to-face interview, and “fallers” were defined as people who had fallen at least once within the past year. WR was calculated as corrected step length divided by corrected cadence, and we divided the subjects into three groups according to the tertile of WR (T1, T2, and T3). We also stratified the participants by gait speed (<1.0 or ≥1.0 m/s).
With reference to the T3 group, the T1 group had a higher odds ratio (OR) of falling in the past year [OR: 1.24, 95% confidence interval (CI): 1.09–1.41], even after adjusting for other covariates. After stratification by gait speed, the same multivariate analyses were conducted. In the participants who walked at 1.0 m/s or faster, the T1 group had a higher OR [1.27, 95% confidence interval (CI): 1.10–1.48], while there was no significant association with fall rate among those who walked slower than 1.0 m/s.
This study revealed that the smallest WR was independently associated with falling in the past year among community-dwelling elderly people, especially elderly people with no deterioration of gait speed. These results suggest that intervention regarding gait pattern, especially WR, would help to prevent falls.
Publication date: Available online 25 August 2018
Source: Gait & Posture
Author(s): Feng Yang, Patrick Cereceres, Mu Qiao
Treadmill-based gait-slip training shows to be effective in reducing the risk of slip-related falls. In previous relevant studies, the number of repeated slip perturbations ranged from 12 to 30.
It is unclear if a reduced number of treadmill-slips can still yield adaptive strategies to lower the likelihood of falls after a slip over ground. This study examined if eight repeated slips on a treadmill reduced the risk of falls among young adults when they were exposed to a novel overground slip.
Forty-three healthy young adults were randomized into either training or control group. The training group underwent an 8-slip perturbation training procedure on a treadmill while the control group received the same number of normal walking trials on the same treadmill. Following the training, both groups were exposed to an unrehearsed slip during overground walking. Their body’s reactions to the novel overground slip were collected by a motion capture system.
The training group exhibited significantly better reactions to the slip than did the control group, evidenced by the lower fall proportion and improved dynamic stability at recovery foot touchdown during the overground slip. No improvement in dynamic stability was detected in the training group at the slipping foot touchdown and recovery foot liftoff.
The results suggested that the shortened perturbation training program may be efficacious in improving responses to a novel overground slip but may not be as effective as protocols using greater number of slips. This study could provide guidance for selecting the number of slips for future perturbation-based training protocols.
Publication date: Available online 25 August 2018
Source: Gait & Posture
Author(s): Sho Nakakubo, Takehiko Doi, Hyuma Makizako, Kota Tsutsumimoto, Ryo Hotta, Satoshi Kurita, Minji Kim, Takao Suzuki, Hiroyuki Shimada
Walk ratio (WR), calculated by dividing step length by cadence, can be used to represent the gait characteristics of human beings to maintain their gait speed.
Research question: The aim of this study was to examine whether WR could distinguish fallers from community-dwelling elderly people.
We recruited 9,205 elderly people (mean age: 73.7 ± 5.6 years, 4,218 men and 4,987 women) from the National Center for Geriatrics and Gerontology – Study of Geriatric Syndromes. Fall history was assessed by face-to-face interview, and “fallers” were defined as people who had fallen at least once within the past year. WR was calculated as corrected step length divided by corrected cadence, and we divided the subjects into three groups according to the tertile of WR (T1, T2, and T3). We also stratified the participants by gait speed (<1.0 or ≥1.0 m/s).
With reference to the T3 group, the T1 group had a higher odds ratio (OR) of falling in the past year [OR: 1.24, 95% confidence interval (CI): 1.09–1.41], even after adjusting for other covariates. After stratification by gait speed, the same multivariate analyses were conducted. In the participants who walked at 1.0 m/s or faster, the T1 group had a higher OR [1.27, 95% confidence interval (CI): 1.10–1.48], while there was no significant association with fall rate among those who walked slower than 1.0 m/s.
This study revealed that the smallest WR was independently associated with falling in the past year among community-dwelling elderly people, especially elderly people with no deterioration of gait speed. These results suggest that intervention regarding gait pattern, especially WR, would help to prevent falls.
Publication date: Available online 25 August 2018
Source: Revista de Logopedia, Foniatría y Audiología
Author(s): Catalina Aceituno, Sofía Aranda, Gisselle Palma, Catalina Pino, Pedro Villegas, Camilo Quezada, Lilian Toledo-Rodríguez
La disartria corresponde a un trastorno adquirido del habla de origen neurológico. Habitualmente, la evaluación se centra en describir los procesos motores del habla afectados, las características perceptuales y determinar el grado de severidad a través de la inteligibilidad del habla. Pocas veces se explora el impacto de este trastorno sobre la calidad de vida de la persona.
Se realizó un estudio cuantitativo, no experimental, transversal, descriptivo y correlacional. Se evaluaron 21 personas con disartria (51.04 ± 13.06 años, 13 hombres) con el protocolo de evaluación de habla para pacientes disártricos y el cuestionario autoadministrado de calidad de vida en hablantes disártricos (QOL-Dys).
Las personas con disartria ven alterada su calidad de vida. Hay una correlación significativa con el grado de severidad de la disartria (r = -.5, p =.02). La inteligibilidad predice de manera significativa el puntaje en el cuestionario de calidad de vida total (R2 =.2, p =.04). El puntaje más bajo se presenta en la percepción de la reacción de los otros (1.66 ± 12.93), y el más alto en enfrentarse a situaciones difíciles (24.38 ± 9.12).
La disartria afecta la calidad de vida de las personas. Se recomienda su evaluación para mejorar la intervención en estas personas.
Dysarthria is an acquired motor speech disorder of neurological origin. Usually assessment focuses on describing the affected motor processes of speech, perceptual characteristics and determining the degree of severity through speech intelligibility, but rarely explores the impact it has on the quality of life of the person.
A quantitative, non-experimental, cross-sectional, descriptive and correlational study was performed. Twenty-one patients with dysarthria (51.04 ± 13.06 years, 13 men) were evaluated with the speech assessment protocol for dysarthric patients and the self-administered quality of life questionnaire for dysarthric speakers (QOL-Dys).
The quality of life of people with dysarthria is affected (QOL), which correlates significantly with the degree of severity of the dysarthria (r = -.5, p = .02). Intelligibility significantly predicts the score of the total quality of life questionnaire (R2 =.2, p = .04). The lowest score occurred in the perception of the reaction of the others (16.66 ± 12.93), and the highest in dealing with difficult situations (24.38 ± 9.12).
Quality of life is affected in people with dysarthria, its assessment is recommended to improve intervention in these people.
Publication date: Available online 25 August 2018
Source: Revista de Logopedia, Foniatría y Audiología
Author(s): Elena Navarro, Ángel Gustavo López Pérez-Díaz, Míriam Sanjuán, María Dolores Calero
El análisis de la fluidez verbal en la vejez ha sido una de las principales estrategias como parte del diagnóstico de la demencia. Así, los estudios han demostrado que, en comparación con ancianos sanos, las personas con demencia muestran un deterioro significativo en fluidez verbal —especialmente en fluidez semántica— incluso después de controlar estadísticamente variables como la edad y el nivel educativo.
El objetivo del estudio realizado es analizar la ejecución de personas mayores en una tarea de fluidez semántica y relacionarla con su rendimiento en otras tareas cognitivas (memoria de trabajo, atención y una prueba de screening), así como determinar la influencia de variables como el nivel educativo, la edad y el sexo en el rendimiento en la tarea de fluidez.
En el estudio han participado un total de 264 personas con una edad media de 79.57 años de la provincia de Granada. Los participantes han sido evaluados con una entrevista estructurada de variables psicosociales, una batería de evaluación neuropsicológica que incluye pruebas de fluidez, memoria, atención, y funcionamiento cognitivo general.
Los resultados muestran diferencias significativas en fluidez verbal en función del estatus cognitivo de las personas y del rango de edad. Igualmente se observan correlaciones significativas entre la fluidez y el resto de pruebas cognitivas aplicadas, siendo una prueba de screening cognitivo la que mejor predice la ejecución en fluidez.
Los datos obtenidos corroboran la importancia de la utilización de pruebas de fluidez en la evaluación psicológica de las personas mayores.
The analysis of verbal fluency in old age has been one of the main strategies as part of the diagnosis of dementia. Thus, studies have shown that, compared to healthy elderly people, those with dementia show a significant deterioration in verbal fluency —especially in semantic fluency— even after the statistical control of variables such as age and educational level.
The objective of the study is to analyze the performance of older people in a task of semantic fluency and relate it to their performance in other cognitive tasks (working memory, attention task and a screening test) as well as to determine the influence of variables such as educational level, age and gender in the fluency task performance.
A total of 264 people with an average age of 79.57 years from the province of Granada participated in the study. Participants were evaluated with a structured interview of psychosocial variables, a battery of neuropsychological assessment that included tests of fluency, memory, attention, and general cognitive functioning.
The results showed significant differences in verbal fluency based on the cognitive status of the persons and the age range. Likewise, significant correlations were observed between fluency and the rest of past cognitive tests, the cognitive screening test being the best predictor of fluency performance.
The data obtained corroborate the importance of the use of fluency tests in the psychological assessment of the elderly.
Publication date: Available online 25 August 2018
Source: Revista de Logopedia, Foniatría y Audiología
Author(s): Catalina Aceituno, Sofía Aranda, Gisselle Palma, Catalina Pino, Pedro Villegas, Camilo Quezada, Lilian Toledo-Rodríguez
La disartria corresponde a un trastorno adquirido del habla de origen neurológico. Habitualmente, la evaluación se centra en describir los procesos motores del habla afectados, las características perceptuales y determinar el grado de severidad a través de la inteligibilidad del habla. Pocas veces se explora el impacto de este trastorno sobre la calidad de vida de la persona.
Se realizó un estudio cuantitativo, no experimental, transversal, descriptivo y correlacional. Se evaluaron 21 personas con disartria (51.04 ± 13.06 años, 13 hombres) con el protocolo de evaluación de habla para pacientes disártricos y el cuestionario autoadministrado de calidad de vida en hablantes disártricos (QOL-Dys).
Las personas con disartria ven alterada su calidad de vida. Hay una correlación significativa con el grado de severidad de la disartria (r = -.5, p =.02). La inteligibilidad predice de manera significativa el puntaje en el cuestionario de calidad de vida total (R2 =.2, p =.04). El puntaje más bajo se presenta en la percepción de la reacción de los otros (1.66 ± 12.93), y el más alto en enfrentarse a situaciones difíciles (24.38 ± 9.12).
La disartria afecta la calidad de vida de las personas. Se recomienda su evaluación para mejorar la intervención en estas personas.
Dysarthria is an acquired motor speech disorder of neurological origin. Usually assessment focuses on describing the affected motor processes of speech, perceptual characteristics and determining the degree of severity through speech intelligibility, but rarely explores the impact it has on the quality of life of the person.
A quantitative, non-experimental, cross-sectional, descriptive and correlational study was performed. Twenty-one patients with dysarthria (51.04 ± 13.06 years, 13 men) were evaluated with the speech assessment protocol for dysarthric patients and the self-administered quality of life questionnaire for dysarthric speakers (QOL-Dys).
The quality of life of people with dysarthria is affected (QOL), which correlates significantly with the degree of severity of the dysarthria (r = -.5, p = .02). Intelligibility significantly predicts the score of the total quality of life questionnaire (R2 =.2, p = .04). The lowest score occurred in the perception of the reaction of the others (16.66 ± 12.93), and the highest in dealing with difficult situations (24.38 ± 9.12).
Quality of life is affected in people with dysarthria, its assessment is recommended to improve intervention in these people.
Publication date: Available online 25 August 2018
Source: Revista de Logopedia, Foniatría y Audiología
Author(s): Elena Navarro, Ángel Gustavo López Pérez-Díaz, Míriam Sanjuán, María Dolores Calero
El análisis de la fluidez verbal en la vejez ha sido una de las principales estrategias como parte del diagnóstico de la demencia. Así, los estudios han demostrado que, en comparación con ancianos sanos, las personas con demencia muestran un deterioro significativo en fluidez verbal —especialmente en fluidez semántica— incluso después de controlar estadísticamente variables como la edad y el nivel educativo.
El objetivo del estudio realizado es analizar la ejecución de personas mayores en una tarea de fluidez semántica y relacionarla con su rendimiento en otras tareas cognitivas (memoria de trabajo, atención y una prueba de screening), así como determinar la influencia de variables como el nivel educativo, la edad y el sexo en el rendimiento en la tarea de fluidez.
En el estudio han participado un total de 264 personas con una edad media de 79.57 años de la provincia de Granada. Los participantes han sido evaluados con una entrevista estructurada de variables psicosociales, una batería de evaluación neuropsicológica que incluye pruebas de fluidez, memoria, atención, y funcionamiento cognitivo general.
Los resultados muestran diferencias significativas en fluidez verbal en función del estatus cognitivo de las personas y del rango de edad. Igualmente se observan correlaciones significativas entre la fluidez y el resto de pruebas cognitivas aplicadas, siendo una prueba de screening cognitivo la que mejor predice la ejecución en fluidez.
Los datos obtenidos corroboran la importancia de la utilización de pruebas de fluidez en la evaluación psicológica de las personas mayores.
The analysis of verbal fluency in old age has been one of the main strategies as part of the diagnosis of dementia. Thus, studies have shown that, compared to healthy elderly people, those with dementia show a significant deterioration in verbal fluency —especially in semantic fluency— even after the statistical control of variables such as age and educational level.
The objective of the study is to analyze the performance of older people in a task of semantic fluency and relate it to their performance in other cognitive tasks (working memory, attention task and a screening test) as well as to determine the influence of variables such as educational level, age and gender in the fluency task performance.
A total of 264 people with an average age of 79.57 years from the province of Granada participated in the study. Participants were evaluated with a structured interview of psychosocial variables, a battery of neuropsychological assessment that included tests of fluency, memory, attention, and general cognitive functioning.
The results showed significant differences in verbal fluency based on the cognitive status of the persons and the age range. Likewise, significant correlations were observed between fluency and the rest of past cognitive tests, the cognitive screening test being the best predictor of fluency performance.
The data obtained corroborate the importance of the use of fluency tests in the psychological assessment of the elderly.
The University of Miami Miller School of Medicine's department of otolaryngology has received a $3 million grant from the National Institutes of Health (NIH) for research on biological treatments and clinical diagnosis of hearing loss. With this new grant, Xue Zhong Liu, MD, PhD, a professor of otolaryngology, human genetics, biochemistry, and pediatrics and the vice chair and Marian & Walter Hotchkiss Chair in Otolaryngology who will spearhead the research as the principal investigator, and his team will expand their genomic and phenotypic deafness database for the clinical care of deaf individuals. They also plan to identify and characterize novel genes for hearing loss using state-of-the-art genomic tools, assess the impact of genomic testing on patients, and conduct preclinical studies of gene- and cell-based therapy approach of CRISPR/Cas9-mediated genome editing to treat hearing loss. Liu said in a press release that recent breakthroughs in genetic screening, gene or cell-based therapeutics, and gene editing for the inner ear can lead to novel therapies for multiple classes of hereditary hearing loss. "Together with our program for genetic hearing loss, these tools and strategies will create a clear path to clinical treatment and accelerate the advent of a new era of personalized medicine for hereditary hearing loss," he said.
The major U.S. hearing health care professional associations (Associations) today announced the release of a consensus paper, "Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness." The consensus paper was developed by a working group representing all associations to provide guidance to the U.S. Food and Drug Administration (FDA) as it develops an over-the-counter (OTC) hearing device classification as mandated by the FDA Reauthorization Act of 2017 (FDARA). The consensus paper, which outlines five evidence-based recommendations related to the safety and effectiveness of this new class of devices, was jointly developed and endorsed by the Academy of Doctors of Audiology (ADA), American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS).
The associations appreciate FDA's recent statement that Section 709 (of FDARA) reflects a careful balance between consumer affordability and access to new technologies, while providing consumer protections to assure safety and effectiveness of OTC hearing aids. The consensus paper introduction, in part, states, "[The Working Group] strongly advocates that any solutions presented to the consumer rely on safe and effective medical devices and include safeguards that optimize consumers' awareness and use of appropriate hearing care treatment."
The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.
The Associations are committed to jointly engaging with the FDA and other stakeholders in the coming months and years, during the continued development of the new OTC hearing device classification.
On the release of the consensus paper, the Association presidents made the following statements:
"The Academy of Doctors of Audiology is pleased to collaborate on the development of consensus recommendations that will help ensure that the Over-the-Counter Hearing Aid Act is implemented by the FDA as it was intended by Congress," said Alicia Spoor, AuD, ADA President. "ADA has been a longstanding advocate for expanded consumer choice and best practices in the delivery of hearing and balance care, and it is extremely gratifying to see alignment within the provider community towards achieving these goals."
"This collaborative effort among the American Academy of Audiology and various hearing associations is just one step in ensuring that consumers and federal regulators are aware of the value of the audiologist for advanced diagnostic testing, hearing and balance evaluations, rehabilitation, and technological expertise," said AAA President and The Hearing Journal board member, Jackie Clark, PhD. "The Academy looks forward to continuing this work to ensure that the safety of the patient is prioritized by the FDA as they develop regulations on over-the-counter hearing devices."
"The American Speech-Language-Hearing Association has welcomed the opportunity to work with fellow hearing professional organizations on a development as important as the introduction of a new category of hearing aids," ASHA President Elise Davis McFarland, PhD, CCC-SLP said. "I urge the FDA to follow our consensus report recommendations. Drawn from years of experience providing hearing care, they stand to contribute significantly to meeting the goal of ensuring safe and effective use of Self-Fit OTC Hearing Devices."
"The International Hearing Society stands with the other professional associations in recommending well-reasoned and thoughtful suggestions in the consensus paper on Self-Fit OTC Hearing Devices for the FDA to use in formulating the rule," said Richard Giles, ACA, BC-HIS, IHS President. "We look forward to jointly engaging with the FDA and others to develop the appropriate regulatory structure and requirements, so these new devices will be both safe and effective for consumers."
The University of Miami Miller School of Medicine's department of otolaryngology has received a $3 million grant from the National Institutes of Health (NIH) for research on biological treatments and clinical diagnosis of hearing loss. With this new grant, Xue Zhong Liu, MD, PhD, a professor of otolaryngology, human genetics, biochemistry, and pediatrics and the vice chair and Marian & Walter Hotchkiss Chair in Otolaryngology who will spearhead the research as the principal investigator, and his team will expand their genomic and phenotypic deafness database for the clinical care of deaf individuals. They also plan to identify and characterize novel genes for hearing loss using state-of-the-art genomic tools, assess the impact of genomic testing on patients, and conduct preclinical studies of gene- and cell-based therapy approach of CRISPR/Cas9-mediated genome editing to treat hearing loss. Liu said in a press release that recent breakthroughs in genetic screening, gene or cell-based therapeutics, and gene editing for the inner ear can lead to novel therapies for multiple classes of hereditary hearing loss. "Together with our program for genetic hearing loss, these tools and strategies will create a clear path to clinical treatment and accelerate the advent of a new era of personalized medicine for hereditary hearing loss," he said.
The major U.S. hearing health care professional associations (Associations) today announced the release of a consensus paper, "Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness." The consensus paper was developed by a working group representing all associations to provide guidance to the U.S. Food and Drug Administration (FDA) as it develops an over-the-counter (OTC) hearing device classification as mandated by the FDA Reauthorization Act of 2017 (FDARA). The consensus paper, which outlines five evidence-based recommendations related to the safety and effectiveness of this new class of devices, was jointly developed and endorsed by the Academy of Doctors of Audiology (ADA), American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS).
The associations appreciate FDA's recent statement that Section 709 (of FDARA) reflects a careful balance between consumer affordability and access to new technologies, while providing consumer protections to assure safety and effectiveness of OTC hearing aids. The consensus paper introduction, in part, states, "[The Working Group] strongly advocates that any solutions presented to the consumer rely on safe and effective medical devices and include safeguards that optimize consumers' awareness and use of appropriate hearing care treatment."
The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.
The Associations are committed to jointly engaging with the FDA and other stakeholders in the coming months and years, during the continued development of the new OTC hearing device classification.
On the release of the consensus paper, the Association presidents made the following statements:
"The Academy of Doctors of Audiology is pleased to collaborate on the development of consensus recommendations that will help ensure that the Over-the-Counter Hearing Aid Act is implemented by the FDA as it was intended by Congress," said Alicia Spoor, AuD, ADA President. "ADA has been a longstanding advocate for expanded consumer choice and best practices in the delivery of hearing and balance care, and it is extremely gratifying to see alignment within the provider community towards achieving these goals."
"This collaborative effort among the American Academy of Audiology and various hearing associations is just one step in ensuring that consumers and federal regulators are aware of the value of the audiologist for advanced diagnostic testing, hearing and balance evaluations, rehabilitation, and technological expertise," said AAA President and The Hearing Journal board member, Jackie Clark, PhD. "The Academy looks forward to continuing this work to ensure that the safety of the patient is prioritized by the FDA as they develop regulations on over-the-counter hearing devices."
"The American Speech-Language-Hearing Association has welcomed the opportunity to work with fellow hearing professional organizations on a development as important as the introduction of a new category of hearing aids," ASHA President Elise Davis McFarland, PhD, CCC-SLP said. "I urge the FDA to follow our consensus report recommendations. Drawn from years of experience providing hearing care, they stand to contribute significantly to meeting the goal of ensuring safe and effective use of Self-Fit OTC Hearing Devices."
"The International Hearing Society stands with the other professional associations in recommending well-reasoned and thoughtful suggestions in the consensus paper on Self-Fit OTC Hearing Devices for the FDA to use in formulating the rule," said Richard Giles, ACA, BC-HIS, IHS President. "We look forward to jointly engaging with the FDA and others to develop the appropriate regulatory structure and requirements, so these new devices will be both safe and effective for consumers."