Otoharmonics, desde la idea al mercado. Un ejemplo reciente de desarrollo biomédico nacional. Marzo 2017
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1 Otoharmonics, desde la idea al mercado Un ejemplo reciente de desarrollo biomédico nacional. Marzo 2017
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20 2016 Se aprueban 2 patentes en USPTO y se levantan en EU, Canadá, India, China, Corea del Sur Japón y Australia LEVO sale al mercado en USA y Canadá Se inician contactos con Grupo GAES (España) para distribución en Latinoamérica
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23 2017 LEVO sale al mercado en UK En proceso de salir al mercado en EU, China, Japón y Corea del Sur
24 SOUND STIMULATION DURING SLEEP A new therapeutic approach for tinnitus Daniel Drexler MD, Mg Sc. Centro de Tinnitus Montevideo Uruguay
25 Idiopathic Tinnitus physiopathogeny (Jastreboff, 1990). input deficit No sound stimulation neural plasticity phantom sensation Over-stimulation Unknowns
26 Specific Sensory afferents Circadian rhythms Sensory neuron Other influences Efferent system Ultradian rhythms
27 Tinnitus Auditory Epilepsy? Mecanismos neurais envolvidos nas convulções audiogênicas em ratos albinos Prof Norberto García Cairasco (USP Rib. Preto)
28 Why acoustic stimulation???? most forms of tinnitus are caused by functional changes; thus, it should be possible to reverse them by proper sound treatment
29 Control Previous acoustic stimulation 1KHz 81 db 24 days
30 cats exposed to acoustic trauma Group 1 sound deprived ambient (SDA) Group 2 enriched acosutic enviroment (EAE) Stimulus with multiple high frecuency tones Evaluation Audiological evaluation Tonotopic reorganization
31 Audiological evaluation EAE SDA
32 Tonotopic reorganization Control SDE EAE
33 ACOUSTIC STIMULATION 1. Pasive function a) Distraction/Masking Noise generators/hearing aids Vernon JA 1977 Attempts to relieve tinnitus. Journal of the American Audiology Society 1977;2: b) Habituation low intensity white noise Jastreboff 1995;McKinney 1995
34 ACOUSTIC STIMULATION 2. Active function a) Prevent cortical reorganization Noreña;Eggermont 2005 b) Spontaneous firing sinchronization at the auditory nerve Eggermont, 1990; Møller, 1984, 1995 c) Hiperexcitability, decrease of inhibitory sinapsis Kiang et al., 1970 d) Increase of spontaneous activity at the cochlear dorsal nucleus Brozoski, Bauer, & Caspary, 2002 e) Eferent system Hazell; 1987
35 Why do we mimetize? Cochlea r damage Cortical reorganization Tinnitus spectral characteristics P. Jastrebof 1990:; Eggermont, Sininger 1995
36 Tinnitus types Pure tone Combination of pure tones (harmonics, 8, 5, etc) White Noise BBN Cricket Combinations
37 Why do we mimetize??? Afferent system Efferent system
38 Why do we mimetize? Edge effect theory P. J. Jastreboff, 1990, Eggermont & Sininger, 1995 trigger
39 Tinnitus mimic Improves cortical representation at damaged frecuencies Decreases edge over-representation
40 Why during sleep? Auditory system processes the incoming information also during sleep. Sensory systems are a main factor in active participation in sleep processes (Velluti, 2005; Velluti and Pedemonte 2002).
41 Levo s treatment advantages type of acoustic stimulation acoustic stimulation during sleep
42 Levo System 1 doctor s audiologist s ipad 2 - patient s ipod 3 patient s customized high fidelity earphones
43 Wi fi connection
44 Levo system advantages Tinnitus mimic allows to create a customized sound Levo delivers high fidelity calibrated sound 8 hours daily stimulation period Treatment objective intensity follow up Sleep quality improvement Levo Remote
45 Sound intensity (ipod steps) pre post First trial Weeks of sound stimulation
46 Second Clinical Trial February - June 2012 Preliminary Results
47 OBJECTIVES evaluate the efficacy and security of Levo treatment in terms of: -intensity reduction of the tinnitus -results in the psychological evaluation of tinnitus research on basic aspects of sound stimulation during sleep
48 Methods 12 patients with idiopatic subjectiv tinnitus Ipod touch with Levo system Customized High Fidelity earphones Counseling on device usage Sound stimulation during sleep Follow up twice a month for 3 months
49 Patient s selection 42 patients with tinnitus were studied 12 patients were selected Inclusion criteria Uni o bilaterla subjective idiopathic tinnitus Permanent + 6 months evolution THI score greater than 17
50 Patient s selection Exclusion criteria: Hearing loss greater than 50 db HTL in more than one frecuency Other Tinnitus treatments in last year Sever sleep disorders Significant depression or ansiety Psicosis
51 Audiometric profile
52 Pre Trial Evaluation Clinical ENT evaluation Clinical sleep evaluation Clinical psychological evaluation of tinnitus : Tinnitus Handicap Inventory (THI) Tinnitus Reaction Questionnaire (TRQ) Tinnitus Functional Index (TFI) Audiological tests: Impedanciometry Audiometry (0,125 to 8 khz) Logoaudiometry, Pain thresholds High frequency audiometry (8 to 16 khz) Otoacustic Emissions (DPOAE,TOAE, SOAE) MRI or CT scan Blood studies Blood cholesterol level Level of blood sugar Hemogram (Complete blood count) TSH T4 Renal function
53 Follow up
54 Results acuphenometry vs mimic less similar more similar 0 10 visual analogic scale acuphenometyry acuphenometry average 3.7 levo mimic levo mimic average7.9 p = e-04
55 Results acuphenometry vs mimic Visual Analogic Scale- EVA Acuphenometry Levo Mimic
56 Results Tinnitus intensity reduction (db)
57 Results
58 Results Averaged Tinnitus intensity reduction 59 db 44.5 db 14.5 db Average tinnitus reduction 14.5 db
59 Intensity reduction 6 db reduction ½ intensity perception 14.5 db reduction more than twice intensity reduction perception 28 times power reduction
60 14.5
61 Ambient noise Levo s tinnitus reduction daily normal ambient noise
62 Tinnitus Awareness Tinnitus at 59 db Tinnitus at 44.5 db
63 Tinnitus awareness Levo Decompensated tinnitus Compensated tinnitus LIFE QUALITY
64 Range Results psychological evaluation of tinnitus Tinnitus Handicap Inventory Newman, Sandridge,& Jacobson, (1998) 25 questions Answers: yes (4), sometimes(2), no (0) Scale Incapacity degree 1 16 No incapacity Mild incapacity Moderate incapacity Severe incapacity
65 Results psychological evaluation of tinnitus Tinnitus Handicap Inventory First THI Second THI Third THI
66 Results psychological evaluation of tinnitus Tinnitus Handicap Inventory First THI = 47 No incapacity Moderate incapacity Second THI = 15 Third THI = 14 THI average reduction = 33 points
67 Results Tinnitus Reaction Questionnaire
68 Conclusions Second clinical trial Tinnitus Mimic is more accurate than acuphenometry Tinnitus intensity reduction. Average 14,5 db Reduction of the tinnitus psychological impact Life quality improvement
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73 References Tinnitus treatment with sound stimulation during sleep. Pedemonte M., Drexler D., Rodio S., Geisinger D., Bianco A., Pol-Fernandes D., Bernhardt V. International Tinnitus Journal. 2010;16(1): Drexler D, López-Paullier M, Rodio S, Bianco A, Geisinger D, Pedemonte M. (2011). Sound Stimulation during sleep improves the condition of patients affected by tinnitus. International State-of-the-Science Meeting on Blast-Related Tinnitus, Northern Virginia, USA. Pedemonte M. (2011) Neurophysiologic bases of tinnitus treatment with sound stimulation during sleep. International State-of-the-Science Meeting on Blast-Related Tinnitus, Northern Virginia, USA. Pedemonte M, Drexler D, López-Paullier M, Rodio S, Bernhardt V, Bianco A, Geisinger D, Pol Fernandes D, Alvarez M. (2011) A new protocol for tinnitus treatment: sound stimulation during sleep. Clinical and electrophysiological approach. X International Tinnitus Seminar, Florianópolis. Brasil. Pedemonte M, Pol-Fernandes D, Drexler D. (2010) Sound stimulation during sleep in tinnitus patients provokes changes in the electroencephalographic waves power spectra. XX European Sleep research Societies Congress, Lisboa, Portugal. Pedemonte M, Drexler D, Rodio S, Bernhardt V. (2009) Sound stimulation during sleep: a therapeutic tool to improve tinnitus. III Congress World Association of Sleep Medicine, Sao Paulo, Brasil. Sleep Medicine, 10(2):50. López Paullier M; Drexler D; Rodio S; Pedemonte, M. (2008) Una nueva terapéutica para el tinnitus: la estimulación sonora durante el sueño. 69na. Jornadas Rioplatenses de Otorrino Laringología, Mar del Plata, Argentina. Pedemonte M, Drexler D, Rodio S, Pol-Fernandes D, Bernhardt V (2008)Tratamiento del tinnitus mediante la estimulación sonora durante el sueño.sexto Congreso Nacional de Otorrino Laringología, Punta del Este. Pedemonte M, Drexler D, Rodio S, Pol-Fernandes D, Bernhardt V. (2008)Sound Stimulation during Sleep for the Tinnitus Treatment: Trans-disciplinary Approach. XXX Congress of Association for Research in Otolaryngology, Phoenix, Arizona. Pedemonte M, Drexler D, Rodio S, Pol-Fernandes D, Bernhardt V. (2007)Sleep Sound Stimulation for Tinnitus Treatment. 2 nd Tinnitus Research Initiative Meeting, Principado de Mónaco, pp:90. Pedemonte M, Drexler D, Pol-Fernandes D, Bernhardt V. (2007) Tinnitus Treatment with Sound Stimulation during Sleep. Cycle. World Federation of Sleep Medicine Sleep Research Societies, Cairns, Australia. Sleep and Biological Rhythms 5(1): 54.
74 URUGUAY País pequeño Nivel educativo Sector creativo Humanismo liberal Libertad Universo digital
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