Jacob Kirkegaard, sonic artist extraordinaire, hailed for his work inspired by natural phenomena and scientific explorations is making music out of the sounds your ears make. Originally trained at the Academy of Media Arts in Cologne, Germany, the Denmark-born artist has numerous critically acclaimed exhibitions and permanent installations under his belt.
Swiss biopharmaceutical company Auris Medical is developing AM-111, a treatment for acute inner ear (sensorineural) hearing loss (ASNHL). Phase 2 and Phase 3 clinical trials of AM-111 resulted in clinically significant hearing improvement among a population of test subjects.
AM-111, which has both European Medicines Agency and US Food & Drug Administration (FDA) orphan drug treatment designation for ASNHL including hearing loss from acoustic trauma, ISSNHL or idiopathic sudden sensorineural hearing loss, and surgery-induced acoustic trauma, is formulated in biodegradable, biocompatible gel that contains an intracellular transporter, and D-JNKI-1 (brimapitide), which is an inhibitor of the JNK stress kinase. AM-111 treatment is delivered in a single dose locally administered into the middle ear by an ENT physician/otolaryngologist.
JNK or c-Jun N-terminal kinase, which is also referred to stress-activated protein kinase (SAPK), is a group of multifunctional-signaling molecules that become active in response to various cellular stresses and to inflammatory mediators. AM-111's 2015 clinical development plan explains that JNK is a signal transmitting enzyme that regulates a number of important cellular activities including apoptosis or death of cells. Here's is a separate research on JNK.
AM-111 prevents/reduces chronic hearing loss and supports recovery processes by entering into cells and attaching to JNK to deter apoptosis reaction and inflammatory response, which may lead to permanent loss of hair cells and cochlear neurons.
At the end of AM-111's Phase 2 clinical trial, which was administered to 210 sufferers of either ASNHL following acute noise trauma or ISSNHL, results show evident improvement in hearing and speech discrimination in patients with severe to profound cases of hearing loss. Results of HEALOS Phase 3 trial, which was conducted in several countries in Europe and Asia double-blind, randomized, and was a placebo-controlled study administered to 256 ASNHL sufferers from severe to profound sudden deafness within 72 hours from onset, provide clinical evidence that AM-111 significantly improved hearing in the subpopulation of patients with profound hearing loss. This study information sheet shows the brief methodology and results released this month.
Following the promising new data from HEALOS trial, Professor Hinrich Staecker, MD, PhD, of the Department of Otolaryngology-Head and Neck Surgery at University of Kansas Medical Center, said in a press release that "Profound sudden deafness can have a major impact on patients' cognitive and auditory function as well as quality of life. It has a poor prognosis, frequently with little or no hearing recovery, and there are no effective treatments. If approved, AM-111 has the potential to address the unmet need for novel therapeutics which can improve hearing during the acute stage of profound sudden deafness and reduce the substantial risk of severe life-long hearing impairment."
Auris Medical plans to discuss the regulatory pathway based on the clinical trials' results.
Swiss biopharmaceutical company Auris Medical is developing AM-111, a treatment for acute inner ear (sensorineural) hearing loss (ASNHL). Phase 2 and Phase 3 clinical trials of AM-111 resulted in clinically significant hearing improvement among a population of test subjects.
AM-111, which has both European Medicines Agency and US Food & Drug Administration (FDA) orphan drug treatment designation for ASNHL including hearing loss from acoustic trauma, ISSNHL or idiopathic sudden sensorineural hearing loss, and surgery-induced acoustic trauma, is formulated in biodegradable, biocompatible gel that contains an intracellular transporter, and D-JNKI-1 (brimapitide), which is an inhibitor of the JNK stress kinase. AM-111 treatment is delivered in a single dose locally administered into the middle ear by an ENT physician/otolaryngologist.
JNK or c-Jun N-terminal kinase, which is also referred to stress-activated protein kinase (SAPK), is a group of multifunctional-signaling molecules that become active in response to various cellular stresses and to inflammatory mediators. AM-111's 2015 clinical development plan explains that JNK is a signal transmitting enzyme that regulates a number of important cellular activities including apoptosis or death of cells. Here's is a separate research on JNK.
AM-111 prevents/reduces chronic hearing loss and supports recovery processes by entering into cells and attaching to JNK to deter apoptosis reaction and inflammatory response, which may lead to permanent loss of hair cells and cochlear neurons.
At the end of AM-111's Phase 2 clinical trial, which was administered to 210 sufferers of either ASNHL following acute noise trauma or ISSNHL, results show evident improvement in hearing and speech discrimination in patients with severe to profound cases of hearing loss. Results of HEALOS Phase 3 trial, which was conducted in several countries in Europe and Asia double-blind, randomized, and was a placebo-controlled study administered to 256 ASNHL sufferers from severe to profound sudden deafness within 72 hours from onset, provide clinical evidence that AM-111 significantly improved hearing in the subpopulation of patients with profound hearing loss. This study information sheet shows the brief methodology and results released this month.
Following the promising new data from HEALOS trial, Professor Hinrich Staecker, MD, PhD, of the Department of Otolaryngology-Head and Neck Surgery at University of Kansas Medical Center, said in a press release that "Profound sudden deafness can have a major impact on patients' cognitive and auditory function as well as quality of life. It has a poor prognosis, frequently with little or no hearing recovery, and there are no effective treatments. If approved, AM-111 has the potential to address the unmet need for novel therapeutics which can improve hearing during the acute stage of profound sudden deafness and reduce the substantial risk of severe life-long hearing impairment."
Auris Medical plans to discuss the regulatory pathway based on the clinical trials' results.
Swiss biopharmaceutical company Auris Medical is developing AM-111, a treatment for acute inner ear (sensorineural) hearing loss (ASNHL). Phase 2 and Phase 3 clinical trials of AM-111 resulted in clinically significant hearing improvement among a population of test subjects.
AM-111, which has both European Medicines Agency and US Food & Drug Administration (FDA) orphan drug treatment designation for ASNHL including hearing loss from acoustic trauma, ISSNHL or idiopathic sudden sensorineural hearing loss, and surgery-induced acoustic trauma, is formulated in biodegradable, biocompatible gel that contains an intracellular transporter, and D-JNKI-1 (brimapitide), which is an inhibitor of the JNK stress kinase. AM-111 treatment is delivered in a single dose locally administered into the middle ear by an ENT physician/otolaryngologist.
JNK or c-Jun N-terminal kinase, which is also referred to stress-activated protein kinase (SAPK), is a group of multifunctional-signaling molecules that become active in response to various cellular stresses and to inflammatory mediators. AM-111's 2015 clinical development plan explains that JNK is a signal transmitting enzyme that regulates a number of important cellular activities including apoptosis or death of cells. Here's is a separate research on JNK.
AM-111 prevents/reduces chronic hearing loss and supports recovery processes by entering into cells and attaching to JNK to deter apoptosis reaction and inflammatory response, which may lead to permanent loss of hair cells and cochlear neurons.
At the end of AM-111's Phase 2 clinical trial, which was administered to 210 sufferers of either ASNHL following acute noise trauma or ISSNHL, results show evident improvement in hearing and speech discrimination in patients with severe to profound cases of hearing loss. Results of HEALOS Phase 3 trial, which was conducted in several countries in Europe and Asia double-blind, randomized, and was a placebo-controlled study administered to 256 ASNHL sufferers from severe to profound sudden deafness within 72 hours from onset, provide clinical evidence that AM-111 significantly improved hearing in the subpopulation of patients with profound hearing loss. This study information sheet shows the brief methodology and results released this month.
Following the promising new data from HEALOS trial, Professor Hinrich Staecker, MD, PhD, of the Department of Otolaryngology-Head and Neck Surgery at University of Kansas Medical Center, said in a press release that "Profound sudden deafness can have a major impact on patients' cognitive and auditory function as well as quality of life. It has a poor prognosis, frequently with little or no hearing recovery, and there are no effective treatments. If approved, AM-111 has the potential to address the unmet need for novel therapeutics which can improve hearing during the acute stage of profound sudden deafness and reduce the substantial risk of severe life-long hearing impairment."
Auris Medical plans to discuss the regulatory pathway based on the clinical trials' results.
Cochlear implant: the family's perspective.
Cochlear Implants Int. 2018 Jan 24;:1-9
Authors: Vieira SS, Dupas G, Chiari BM
Abstract
OBJECTIVE: To understand the family's experience of a child who uses a cochlear implant (CI). Specifically, to identify the difficulties, changes, and feelings entailed by deafness and the use of the CI; the coping strategies; and to understand the role of the family for the child with a CI.
METHOD: Qualitative research, using Symbolic Interactionism and Straussian Grounded Theory as the theoretical and methodological frameworks, respectively. Data collection instrument: semi-structured interview. A total of 9 families (32 individuals) participated in the study. The children's ages ranged from 6 to 11 years old (mean = 8.9 years old).
RESULTS: Their experience is described in the following categories: Having to fight for results, Coping with difficult situations, Recognizing that you are not alone, Learning to overcome, and Having one's life restored by the implant.
CONCLUSION: Cochlear implantation changes the direction of the child and the family's life by restoring the child's opportunity to hear and to obtain good results in her personal, social, and academic development. Even after implantation, the child continues to experience difficulties and requires the family's mobilization in order to be successful. The family is the principal actor in the process of the child's rehabilitation.
PMID: 29363411 [PubMed - as supplied by publisher]
Feasibility and reliability of a virtual reality oculus platform to measure sensory integration for postural control in young adults.
Physiother Theory Pract. 2018 Jan 24;:1-16
Authors: Lubetzky AV, Kary EE, Harel D, Hujsak B, Perlin K
Abstract
BACKGROUND: Using Unity for the Oculus Development-Kit 2, we have developed an affordable, portable virtual reality platform that targets the visuomotor domain, a missing link in current clinical assessments of postural control. Here, we describe the design and technical development as well as report its feasibility with regards to cybersickness and test-retest reliability in healthy young adults.
METHOD: Our virtual reality paradigm includes two functional scenes ('City' and 'Park') and four moving dots scenes. Twenty-one healthy young adults were tested twice, one to two weeks apart. They completed a simulator sickness questionnaire several times per session. Their postural sway response was recorded from a forceplate underneath their feet while standing on the floor, stability trainers, or a Both Sides Up (BOSU) ball. Sample entropy, postural displacement, velocity, and excursion were calculated and compared between sessions given the visual and surface conditions.
RESULTS: Participants reported slight-to-moderate transient side effects. Intra-Class Correlation values mostly ranged from 0.5 to 0.7 for displacement and velocity, were above 0.5 (stability trainer conditions) and above 0.4 (floor mediolateral conditions) for sample entropy, and minimal for excursion.
CONCLUSION: Our novel portable VR platform was found to be feasible and reliable in healthy young adults.
PMID: 29364733 [PubMed - as supplied by publisher]
Feasibility and reliability of a virtual reality oculus platform to measure sensory integration for postural control in young adults.
Physiother Theory Pract. 2018 Jan 24;:1-16
Authors: Lubetzky AV, Kary EE, Harel D, Hujsak B, Perlin K
Abstract
BACKGROUND: Using Unity for the Oculus Development-Kit 2, we have developed an affordable, portable virtual reality platform that targets the visuomotor domain, a missing link in current clinical assessments of postural control. Here, we describe the design and technical development as well as report its feasibility with regards to cybersickness and test-retest reliability in healthy young adults.
METHOD: Our virtual reality paradigm includes two functional scenes ('City' and 'Park') and four moving dots scenes. Twenty-one healthy young adults were tested twice, one to two weeks apart. They completed a simulator sickness questionnaire several times per session. Their postural sway response was recorded from a forceplate underneath their feet while standing on the floor, stability trainers, or a Both Sides Up (BOSU) ball. Sample entropy, postural displacement, velocity, and excursion were calculated and compared between sessions given the visual and surface conditions.
RESULTS: Participants reported slight-to-moderate transient side effects. Intra-Class Correlation values mostly ranged from 0.5 to 0.7 for displacement and velocity, were above 0.5 (stability trainer conditions) and above 0.4 (floor mediolateral conditions) for sample entropy, and minimal for excursion.
CONCLUSION: Our novel portable VR platform was found to be feasible and reliable in healthy young adults.
PMID: 29364733 [PubMed - as supplied by publisher]
Genetics of Deafness.
Int J Audiol. 2018 Feb;57(2):158
Authors: Vento B
PMID: 29363406 [PubMed - in process]
Auditory-Verbal Therapy.
Int J Audiol. 2018 Feb;57(2):156
Authors: White J
PMID: 29363405 [PubMed - in process]
Genetics of Deafness.
Int J Audiol. 2018 Feb;57(2):158
Authors: Vento B
PMID: 29363406 [PubMed - in process]
Auditory-Verbal Therapy.
Int J Audiol. 2018 Feb;57(2):156
Authors: White J
PMID: 29363405 [PubMed - in process]
Genetics of Deafness.
Int J Audiol. 2018 Feb;57(2):158
Authors: Vento B
PMID: 29363406 [PubMed - in process]
Auditory-Verbal Therapy.
Int J Audiol. 2018 Feb;57(2):156
Authors: White J
PMID: 29363405 [PubMed - in process]
Genetics of Deafness.
Int J Audiol. 2018 Feb;57(2):158
Authors: Vento B
PMID: 29363406 [PubMed - in process]
Auditory-Verbal Therapy.
Int J Audiol. 2018 Feb;57(2):156
Authors: White J
PMID: 29363405 [PubMed - in process]
