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Tommy RA¶nngren is the Chief Executive Officer of Akloma Biosciences AB, a founder of the company and a member of the Board of Directors. Ebbe Damm is the Chief Financial and Operating Officer of Akloma Bioscience AB, a founder of the company and a member of the Board of Directors. Benny Johansson is the Director of Research and Development of Akloma Biosciences AB, a founder of the company and a member of the Board of Directors.
How to cite this article Cevette MJ, Barrs DM, Patel A, Conroy KP, Sydlowski S, Nelson BNNGA, Stepanek J, et al. Background: Recent studies in noise-induced and idiopathic sensorineural hearing loss have suggested that magnesium supplementation may lessen both hearing loss and the severity of tinnitus in patients.
Descriptions of tinnitus date back to the time of ancient Egypt, yet science has failed to unravel the mysterious underlying mechanisms that produce these subjective auditory perceptions of sound.
Despite these encouraging findings, no controlled study has examined the effect of magnesium supplementation for patients with moderate to severe tinnitus. Between March 6 and December 10, 2008, patients aged 18 years or older who were seen for an audiological evaluation at Mayo Clinic in Scottsdale, Arizona, and who had a Tinnitus Distress Rating (TDR) scale score from 3 through 8 (Figure 1) were eligible for the study.
Participants were given a daily magnesium supplement, 532 mg (Mg Plus Protein, 133-mg tablets; Miller Pharmacal Group, Carol Stream, Illinois).
The primary outcome measures were comparisons of TDR scale scores and THI scores as converted to TSS grades at baseline and the end of the study. The present study indicated that subjects showed significant improvement in their self-rating of tinnitus with a magnesium supplement of 532 mg daily for 3 months.
RA¶nngren is a board member of the Fotografiska Museum in Stockholm, as well as a board member of the following companies: VlA¤rden AB, Photography Art Investment AB, H2 Management, HATT et SA–NER and Ronngren Holdings AB. RA¶nngren brings a wealth of financial and commercial accomplishment to the company having lived and worked abroad with diverse companies. Ninna has a long and proven track record within the media industry, with a number of managerial positions within TV4, SVT, DN, RTL and MTG radio on her CV. Damm has extensive diverse experience in the fields of corporate management and business development. Johansson is a Senior Research Scientist at Scandinavian International University at A–rebro.
Johansson is the recipient of a Swedish innovation award for his work in the fields of clinical chemistry, drug and toxicology analysis. Jerling has more than 10 years experience of clinical practice working as an MD, and more than 18 years experience of drug development in the pharmaceutical industry. Jerling has been involved in the design, conduct and analysis of numerous clinical studies and frequently interacted with regulatory authorities and ethics committees on matters related to clinical studies. Hultberg has more than 30 years life science industry experience, including 15 years of leadership positions in Strategic Partnering and Business Development at AstraZeneca. Linde is the General Counsel of Akloma Bioscience AB with more than 20 years of in-house and private legal practice experience with a focus on global life sciences. Linde worked at the law firm of Mannheimer Swartling in Stockholm and before that she was the Vice-President of Endo Pharmaceuticals in the United States. Further epidemiological evidence indicates that all age groups of Americans fall short of the recommended daily allowance for magnesium by 100 mg daily. These perceptions may be manifestations of damage resulting from noise exposure, ototoxicity, or other abnormal conditions of the auditory system. Additionally, no study to date has examined self-reported tinnitus severity before and after magnesium supplementation. The TDR was adapted from an existing pain scale, with the subject rating him- or herself between 0 (no tinnitus) to 10 (worst possible tinnitus). The Tinnitus Handicap Inventory is a 25-item self-report questionnaire that the patient can complete in about 10 minutes.
A review by the Division of Cardiovascular Diseases indicated that daily magnesium supplementation at the level of 532 mg was benign for heart patients whose kidney function was normal.
After beginning magnesium supplementation, the participants rated themselves daily for 3 months using the TDR. The data collected for each participant included informed consent, sex, date of birth, hearing threshold at 8 frequencies (250, 500, 1,000, 2,000, 3,000, 4,000, 6,000, and 8,000 Hz), weekly diaries of daily TDR ratings of tinnitus, THI questionnaires at baseline and the end of the study, dates of first and last dose of magnesium, number of tablets used, reason for discontinuation, and adverse events.
Of these, 2 patients (8%) discontinued the study because of adverse events and subsequently had no follow-up data. Change in tinnitus rating in 26 patients from baseline to 3 months after treatment with magnesium. In fact, significant improvement in the TDR occurred as early as 1 month into the study, suggesting that benefit of magnesium supplementation occurred early in treatment and was sustained throughout the 3 months of the study.

Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine.
PhD, Department of Otolaryngology, Section of Audiology - Mayo Clinic - Scottsdale - AC - United States. MD, Department of Otolaryngology, Head and Neck Surgery - Mayo Clinic - Scottsdale - United States. AuD, Department of Otolaryngology, Section of Audiology - Mayo Clinic - Scottsdale - United States. AuD, Section of Audiology - Cleveland Clinic Head and Neck Institute - Cleveland - United States. BS, Department of Otolaryngology, Section of Audiology - Mayo Clinic - Scottsdale - United States. MD, Division of Preventive, Occupational and Aerospace Medicine - Mayo Clinic - Scottsdale - United States. RA¶nngren is a venture capital investor highly experienced in the fields of international business development and instrumental in achieving market and sales growth. He is a global entrepreneur who has owned and managed several start-up companies as well as a large franchise. His career success in owning and operating many profitable business ventures are indicative of his talents in driving strategy, leadership, and operations. He also holds several patent applications and is a regular speaker at national and international conferences in the fields of clinical chemistry, mental training, bioelectrography and subtle qualities of water. Jerling has an MD and PhD degree from the Karolinska Institute and is a board certified specialist in Clinical Pharmacology. He has been head of clinical pharmacology departments in three companies including Astra, Novo Nordisk and CV Therapeutics in California. He began his career at KabiGen AB where he advanced from Research Scientist to the Director of Business Development.
She has worked extensively with branded and generic pharmaceuticals, medical devices, academic, and corporate clients. Purpose: The purpose of this study was to examine any potential benefit in lessening the severity of tinnitus in patients taking supplemental magnesium. However, many individuals have idiopathic tinnitus for which no specific cause can be determined. For example, the putative magnesium mechanism within the auditory system involves a metabolic cellular cascade of events. The purpose of this study was to examine any potential lessening of the severity of tinnitus in patients receiving magnesium supplementation. The Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale (TSS) (Table 1), developed by McCombe et al. A review by the Mayo Pharmacy indicated that there were no major drug interactions with magnesium at the levels of the current protocol. Differences in TDR scores before and after supplementation were compared to determine any effect of supplementation on a participant's self-rated tinnitus. The adverse event data included the date of onset and whether the adverse event led to premature discontinuation of the intervention. The THI was measured at the time of discontinuation if a patient discontinued the study before 3 months. Johansson specializes in experimental clinical chemistry and has authored numerous scientific papers. At Astra he was head and medical leader of a Phase I unit conducting early drug development studies.
Hultberg managed a team of 45 individuals across the globe including Sweden, the UK and the U.S. During his career he has focused on generating externalization strategy, evaluation of commercial opportunities and academic collaborations. Linde has also worked in the Legal Divisions at AstraZeneca, Bristol Myers Squibb, and DuPont Pharmaceuticals. Research Design: The study was a single-arm, open-label, before-and-after study of oral magnesium (532 mg per day) in 26 patients for 3 months. Although often presenting in conjunction with hearing loss, the magnitude of hearing loss does not necessarily correspond with the severity of tinnitus. Specifically, magnesium deficiency leads to increased permeability of the calcium channel in the hair cells with a consequent over-influx of calcium, an increased release of glutamate via exocytosis, and overstimulation of N-methyl-D-aspartate receptors on the auditory nerve fibers. In addition, all participants completed another THI after 3 months of magnesium supplementation.

The mean hearing thresholds and mean TDR scores before and after treatment were assessed using a paired t test.
For the subjects lost to follow-up, we assumed for the purposes of this analysis that there was no benefit from treatment. Effect of various serotoninergically induced manipulations on audiogenic seizures in magnesium-deficient mice. Influence of dietary magnesium on the amplitude of wave V of the auditory brainstem response.
Guidelines for the grading of tinnitus severity: the results of a working group commissioned by the British Association of Otolaryngologists, Head and Neck Surgeons, 1999. He had additional responsibility for alliance liaisons in Japan, Australia, Canada and China and was instrumental in creating, developing and leading the Global Discovery Alliances Division. Through his leadership and management, he has developed an extensive global network within the life sciences industry and delivered a number of complex transactions worldwide. Tinnitus severity was evaluated and recorded daily by the patient using the Tinnitus Distress Rating (TDR) scale of 0 (no tinnitus) to 10 (worst possible tinnitus). Recent studies of both noise-induced hearing loss and idiopathic sensorineural hearing loss have suggested that magnesium supplementation may lessen the severity of tinnitus in patients. The THI scores were converted to the grades of the TSS for the purpose of categorizing the numeric values of the THI into a reliable 5-item grading scheme. These participants were included because if noncompleters doing poorly enough to drop out were not analyzed, then selection bias would be likely. Johansson worked at the Institute of Clinical Chemistry at SUS, MalmA¶, Sweden and at AstraZeneca.
Jerling has also worked with medical devices from a development and safety reporting point of view. The Tinnitus Handicap Inventory (THI) was administered before and at the end of the study, and scores were converted to the grades of the 5-item Tinnitus Severity Scale (TSS). This relationship suggests these processes may be linked by underlying imbalances at the level of the hair cell. Magnesium improved hearing recovery and lessened tinnitus in patients with idiopathic sudden hearing loss (Gordin et al., 2002).
Therefore, subjects with no follow-up were treated as though they had no improvement and were included in the analysis. The purpose of this phase 2 study was to investigate whether the treatment was effective at all, and, as such, a placebo control was not performed. The possible influence of magnesium and its antagonist, calcium, has been discussed in the literature as a contributing factor in the mitigation of noise-induced hearing loss, ototoxicity, and the hyperexcitability of the auditory system (Cevette et al., 2003). Johansson is a member of the International Society for Mental Training and Excellence (ISMTE) and the International Union of Scientific and Applied Bioelectrography. All data were collected at Mayo Clinic in Scottsdale, Arizona, between March 6 and December 10, 2008. Permanent and temporary changes in auditory function have been linked to nutritional deficiencies of magnesium. Based on the results of the present study, the authors have initiated a Phase 3 study using a placebo and double-blinding to control for factors unrelated to the magnesium supplementation. There was no significant change in hearing thresholds from 250 Hz through 8,000 Hz for either ear during the duration of the study (Table 2).
Data Collection and Analysis: The main outcome measures were mean TDR scale scores and THI scores as converted to TSS grades. There was a significant decrease in the severity of tinnitus for subjects on the basis of their THI responses (P=.03). Those patients whose THI scores translated to "slight" or greater grade on the TSS before the intervention showed a significant decrease in the severity of their tinnitus (P=.008) (Table 3). Figure 3 graphically represents the change in TDR in 26 patients from baseline to 3 months after treatment with magnesium. Conclusion: The results suggest that magnesium may have a beneficial effect on perception of tinnitus-related handicap when scored with the THI. After supplementation, by intention-to-treat analysis, 14 of 26 patients (54%) continued to have more than slight impairment; by analysis of patients who completed the study, only 7 of 19 patients (37%) had more than slight impairment.

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