Preclinical prospects of investigational agents for hearing loss treatment

References

• Le Prell CG, Brewer CC, Campbell KCM. The audiogram: detection of pure-tone stimuli in ototoxicity monitoring and assessments of investigational medicines for the inner ear. J Acoust Soc Am. 2022;152(1):470–490. doi: 10.1121/10.0011739
   PubMed Web of Science ®Google Scholar
• Agrawal Y, Platz EA, Niparko JK. Prevalence of hearing loss and differences by demographic characteristics among US adults: data from the national health and nutrition examination survey, 1999-2004. Arch Intern Med. 2008;168(14):1522–1530. doi: 10.1001/archinte.168.14.1522
   PubMed Web of Science ®Google Scholar
• Füllgrabe C, Moore BCJ, Stone MA. Age-group differences in speech identification despite matched audiometrically normal hearing: contributions from auditory temporal processing and cognition. Front Aging Neurosci. 2015;6:347. doi: 10.3389/fnagi.2014.00347
   PubMed Web of Science ®Google Scholar
• Humes LE. U.S. population data on hearing loss, trouble hearing, and hearing-device use in adults: national health and nutrition examination survey, 2011-12, 2015-16, and 2017-20. Trends Hear. 2023;27:23312165231160978. doi: 10.1177/23312165231162727
   Web of Science ®Google Scholar
• de Gruy JA, Spankovich C, Hopper S, et al. Defining hearing loss severity based on pure tone audiometry and self-reported perceived hearing difficulty, National health and nutrition examination survey. J Am Acad Audiol. 2023 May 17; Online ahead of print. doi:10.1055/a-2095-7002
   Google Scholar
• Dragon JM, Grewal MR, Irace AL, et al. Prevalence of subclinical hearing loss in the United States. Otolaryngol Head Neck Surg. 2023 Mar 24; Online ahead of print. doi: 10.1002/ohn.326
   Web of Science ®Google Scholar
• Carroll YI, Eichwald J, Scinicariello F, et al. Vital signs: noise-induced hearing loss among adults - United States 2011-2012. MMWR Morb Mortal Wkly Rep. 2017;66(5):139–144. doi: 10.15585/mmwr.mm6605e3
   PubMed Web of Science ®Google Scholar
• Grant KJ, Parthasarathy A, Vasilkov V, et al. Predicting neural deficits in sensorineural hearing loss from word recognition scores. Sci Rep. 2022;12(1):8929. doi: 10.1038/s41598-022-13023-5
   PubMed Web of Science ®Google Scholar
• Dillard LK, Arunda MO, Lopez-Perez L, et al. Prevalence and global estimates of unsafe listening practices in adolescents and young adults: a systematic review and meta-analysis. BMJ Glob Health. 2022;7(11):e010501. doi: 10.1136/bmjgh-2022-010501
   PubMed Web of Science ®Google Scholar
• Livingston G, Sommerlad A, Orgeta V, et al. Dementia prevention, intervention, and care. Lancet. 2017;390(10113):2673–2734. doi: 10.1016/S0140-6736(17)31363-6
   PubMed Web of Science ®Google Scholar
• Livingston G, Huntley J, Sommerlad A, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet commission. Lancet. 2020;396(10248):413–446. doi: 10.1016/S0140-6736(20)30367-6
   PubMed Web of Science ®Google Scholar
• Warner-Czyz AD, Roland JT Jr., Thomas D, et al. American cochlear implant alliance task force guidelines for determining cochlear implant candidacy in children. Ear Hear. 2022;43(2):268–282. doi: 10.1097/AUD.0000000000001087
   PubMed Web of Science ®Google Scholar
• Zeitler DM, Prentiss SM, Sydlowski SA, et al. American cochlear implant alliance task force: recommendations for determining cochlear implant candidacy in adults. Laryngoscope. 2023 Jul 12; Online ahead of print. doi: 10.1002/lary.30879
   Web of Science ®Google Scholar
• Dillon MT, Kocharyan A, Daher GS, et al. American cochlear implant alliance task force guidelines for clinical assessment and management of adult cochlear implantation for single-sided deafness. Ear Hear. 2022;43(6):1605–1619. doi: 10.1097/AUD.0000000000001260
   PubMed Web of Science ®Google Scholar
• Park LR, Griffin AM, Sladen DP, et al. American cochlear implant alliance task force guidelines for clinical assessment and management of cochlear implantation in children with single-sided deafness. Ear Hear. 2022;43(2):255–267. doi: 10.1097/AUD.0000000000001204
   PubMed Web of Science ®Google Scholar
• Sawyer CS, Armitage CJ, Munro KJ, et al. Correlates of hearing aid use in UK adults: self-reported hearing difficulties, social participation, living situation, health, and demographics. Ear Hear. 2019;40(5):1061–1068. doi: 10.1097/AUD.0000000000000695
   PubMed Web of Science ®Google Scholar
• Lin FR, Chadha S. Over-the-counter hearing aids - using regulatory policy to improve public health. N Engl J Med. 2023;388(23):2117–2119. doi: 10.1056/NEJMp2302355
   PubMedGoogle Scholar
• Tucci DL, Califf RM. Over-the-counter hearing aids: from research to policy to practice. JAMA. 2022;328(23):2299–2300. doi: 10.1001/jama.2022.22123
   PubMed Web of Science ®Google Scholar
• Almufarrij I, Dillon H, Munro KJ. Do we need audiogram-based prescriptions? A systematic review. Int J Audiol. 2023;62(6):500–511. doi: 10.1080/14992027.2022.2064925
   PubMed Web of Science ®Google Scholar
• Abi-Hachem RN, Zine A, Van De Water TR. The injured cochlea as a target for inflammatory processes, initiation of cell death pathways and application of related otoprotectives strategies. Recent Pat CNS Drug Discovery. 2010;5(2):147–163. doi: 10.2174/157488910791213121
   PubMedGoogle Scholar
• Dinh CT, Goncalves S, Bas E, et al. Molecular regulation of auditory hair cell death and approaches to protect sensory receptor cells and/or stimulate repair following acoustic trauma. Front Cell Neurosci. 2015;9:96.
   PubMed Web of Science ®Google Scholar
• Henderson D, Bielefeld EC, Harris KC, et al. The role of oxidative stress in noise-induced hearing loss. Ear Hear. 2006;27(1):1–19. doi: 10.1097/01.aud.0000191942.36672.f3
   PubMed Web of Science ®Google Scholar
• Le Prell CG, Yamashita D, Minami S, et al. Mechanisms of noise-induced hearing loss indicate multiple methods of prevention. Hear Res. 2007;226(1–2):22–43. doi: 10.1016/j.heares.2006.10.006
   PubMed Web of Science ®Google Scholar
• Wang J, Puel JL. Presbycusis: An update on cochlear mechanisms and therapies. J Clin Med. 2020;9(1):218. doi: 10.3390/jcm9010218
   PubMed Web of Science ®Google Scholar
• Lewis RM. From bench to booth: examining hair-cell regeneration through an audiologist’s scope. J Am Acad Audiol. 2021;32(10):654–660. doi: 10.1055/s-0041-1731700
   PubMed Web of Science ®Google Scholar
• Schilder AGM, Su MP, Blackshaw H, et al. Hearing protection, restoration, and regeneration: an overview of emerging therapeutics for inner ear and central hearing disorders. Otol Neurotol. 2019;40(5):559–570. doi: 10.1097/MAO.0000000000002194
   PubMed Web of Science ®Google Scholar
• Mukherjea D, Ghosh S, Bhatta P, et al. Early investigational drugs for hearing loss. Expert Opin Investig Drugs. 2015;24(2):201–217. doi: 10.1517/13543784.2015.960076
   PubMed Web of Science ®Google Scholar
• Sha SH, Schacht J. Emerging therapeutic interventions against noise-induced hearing loss. Expert Opin Investig Drugs. 2017;26(1):85–96. doi: 10.1080/13543784.2017.1269171
   PubMed Web of Science ®Google Scholar
• Ajay E, Gunewardene N, Richardson R. Emerging therapies for human hearing loss. Expert Opin Biol Ther. 2022;22(6):689–705. doi: 10.1080/14712598.2022.2072208
   PubMed Web of Science ®Google Scholar
• Gay RD, Enke YL, Kirk JR, et al. Therapeutics for hearing preservation and improvement of patient outcomes in cochlear implantation-Progress and possibilities. Hear Res. 2022;426:108637. doi: 10.1016/j.heares.2022.108637
   PubMed Web of Science ®Google Scholar
• Le Prell CG, Roth K, Campbell KCM. Towards clinical pharmacologic otoprotection. In: Hatzopoulos S, Ciorba A Krumm M, editors. Advances in audiology, speech pathology, and hearing science, volume 2: otoprotection, regeneration and telemedicine. (NJ): Apple Academic Press; 2020. p. 179–231. doi: 10.1201/9780429292620-10
   Google Scholar
• Le Prell CG, Bao J. Prevention of noise-induced hearing loss: potential therapeutic agents. In: Le Prell C, Henderson D, and Fay R, editors. Noise-induced hearing loss: scientific advances, springer handbook of auditory research. (NY): Springer Science+Business Media, LLC; 2012. p. 285–338. 10.1007/978-1-4419-9523-0_13
   Google Scholar
• Peixoto Pinheiro B, Müller M, Bös M, et al. A potassium channel agonist protects hearing function and promotes outer hair cell survival in a mouse model for age-related hearing loss. Cell Death Dis. 2022;13(7):595. doi: 10.1038/s41419-022-04915-5
   PubMedGoogle Scholar
• Hammill TL. An evidence-base and implementation framework for promoting best practices in pharmaceutical interventions for hearing loss (PIHL) [Dissertation]. Austin, Texas, U.S: The University of Texas at Austin; 2017. https://repositories.lib.utexas.edu/handle/2152/62240
   Google Scholar
• Fox DJ, Cooper MD, Speil CA, et al. D-methionine reduces tobramycin-induced ototoxicity without antimicrobial interference in animal models. J Cyst Fibros. 2016;15(4):518–530. doi: 10.1016/j.jcf.2015.06.005
   PubMed Web of Science ®Google Scholar
• Duan M, Qiu J, Laurell G, et al. Dose and time-dependent protection of the antioxidant N-L-acetylcysteine against impulse noise trauma. Hear Res. 2004;192(1–2):1–9. doi: 10.1016/j.heares.2004.02.005
   PubMed Web of Science ®Google Scholar
• Pourbakht A, Yamasoba T. Ebselen attenuates cochlear damage caused by acoustic trauma. Hear Res. 2003;181(1–2):100–108. doi: 10.1016/S0378-5955(03)00178-3
   PubMed Web of Science ®Google Scholar
• Kil J, Lobarinas E, Spankovich C, et al. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomized double blind placebo-controlled phase 2 clinical trial. Lancet. 2017;390(10098):969–979. doi: 10.1016/S0140-6736(17)31791-9
   PubMed Web of Science ®Google Scholar
• Cousins RP. Medicines discovery for auditory disorders: challenges for industry. J Acoust Soc Am. 2019; 146(5):3652–3667. doi: 10.1121/1.5132706
   PubMed Web of Science ®Google Scholar
• Cousins R. Hearing loss drug discovery and medicinal chemistry: current status, challenges, and opportunities. Prog Med Chem. 2022;61:1–91.
   PubMedGoogle Scholar
• Bielefeld EC, Kobel MJ. Advances and challenges in pharmaceutical therapies to prevent and repair cochlear injuries from noise. Front Cell Neurosci. 2019;13:285. doi: 10.3389/fncel.2019.00285
   PubMed Web of Science ®Google Scholar
• Isherwood B, Gonçalves AC, Cousins R, et al. The global hearing therapeutic pipeline: 2021. Drug Discov Today. 2022;27(3):912–922. doi: 10.1016/j.drudis.2021.11.009
   PubMed Web of Science ®Google Scholar
• Le Prell CG. Prevention of noise-induced hearing loss using investigational medicines for the inner ear: previous trial outcomes should inform future trial design. Antioxid Redox Signal. 2022;36(16–18):1171–1201. doi: 10.1089/ars.2021.0166
   PubMed Web of Science ®Google Scholar
• Le Prell CG. Investigational medicinal products for the inner ear: review of clinical trial characteristics in ClinicalTrials.Gov. J Am Acad Audiol. 2021; 32(10):670–694. doi: 10.1055/s-0041-1735522
   PubMed Web of Science ®Google Scholar
• Marx M, Younes E, Chandrasekhar SS, et al. International consensus (ICON) on treatment of sudden sensorineural hearing loss. Eur Ann Otorhinolaryngol Head Neck Dis. 2018;135(1s):S23–s28. doi: 10.1016/j.anorl.2017.12.011
   PubMedGoogle Scholar
• Duinkerken CW, de Weger VA, Dreschler WA, et al. Transtympanic sodium thiosulfate for prevention of cisplatin-induced ototoxicity: a randomized clinical trial. Otol Neurotol. 2021;42(5):678–685. doi: 10.1097/MAO.0000000000003069
   PubMed Web of Science ®Google Scholar
• Brock PR, Maibach R, Childs M, et al. Sodium thiosulfate for protection from cisplatin-induced hearing loss. N Engl J Med. 2018;378(25):2376–2385. doi: 10.1056/NEJMoa1801109
   PubMed Web of Science ®Google Scholar
• Freyer DR, Chen L, Krailo MD, et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63–74. doi: 10.1016/S1470-2045(16)30625-8
   PubMed Web of Science ®Google Scholar
• Campbell KCM, Le Prell CG. Drug-induced ototoxicity: diagnosis and monitoring. Drug Saf. 2018;41(5):451–464. doi: 10.1007/s40264-017-0629-8
   PubMed Web of Science ®Google Scholar
• Dhillon S. Sodium thiosulfate: pediatric first approval. Paediatr Drugs. 2023; 25(2):239–244. doi: 10.1007/s40272-022-00550-x
   PubMed Web of Science ®Google Scholar
• Jiang L, Wang D, He Y, et al. Advances in gene therapy hold promise for treating hereditary hearing loss. Mol Ther. 2023;31(4):934–950. doi: 10.1016/j.ymthe.2023.02.001
   PubMed Web of Science ®Google Scholar
• Ohlemiller KK. Mouse methods and models for studies in hearing. J Acoust Soc Am. 2019;146(5):3668–3680. doi: 10.1121/1.5132550
   PubMed Web of Science ®Google Scholar
• Escabi CD, Frye M, Lobarinas E. The rat animal model for noise-induced hearing loss. J Acoust Soc Am. 2019;146(5):3692–3709. doi: 10.1121/1.5132553
   PubMed Web of Science ®Google Scholar
• Holt AG, Kallakuri S, Braun R, et al. The rat as a model for studying noise injury and otoprotection. J Acoust Soc Am. 2019;146(5):3681–3691. doi: 10.1121/1.5131344
   PubMed Web of Science ®Google Scholar
• Radziwon K, Sheppard A, Salvi RJ. Psychophysical changes in temporal processing in chinchillas with noise-induced hearing loss: a literature review. J Acoust Soc Am. 2019;146(5):3733–3742. doi: 10.1121/1.5132292
   PubMed Web of Science ®Google Scholar
• Trevino M, Lobarinas E, Maulden AC, et al. The chinchilla animal model for hearing science and noise-induced hearing loss. J Acoust Soc Am. 2019;146(5):3710–3732. doi: 10.1121/1.5132950
   PubMed Web of Science ®Google Scholar
• Naert G, Pasdelou M-P, Le Prell CG. Use of the guinea pig in studies on the development and prevention of acquired sensorineural hearing loss, with an emphasis on noise. J Acoust Soc Am. 2019;146(5):3743–3769. doi: 10.1121/1.5132711
   PubMed Web of Science ®Google Scholar
• Burton JA, Valero MD, Hackett TA, et al. The use of nonhuman primates in studies of noise injury and treatment. J Acoust Soc Am. 2019;146(5):3770–3789. doi: 10.1121/1.5132709
   PubMed Web of Science ®Google Scholar
• Campbell KCM, Meech RP, Klemens JJ, et al. Prevention of noise- and drug-induced hearing loss with D-methionine. Hear Res. 2007;226(1–2):92–103. doi: 10.1016/j.heares.2006.11.012
   PubMed Web of Science ®Google Scholar
• Le Prell CG, Hughes LF, Miller JM. Free radical scavengers vitamins A, C, and E plus magnesium reduce noise trauma. Free Rad Biol Med. 2007;42(9):1454–1463. doi: 10.1016/j.freeradbiomed.2007.02.008
   PubMed Web of Science ®Google Scholar
• Gittleman S, Le Prell CG, Hammill T. Octave band noise exposure: Laboratory models and otoprotection efforts. J Acoust Soc Am. 2019; 146(5):3800–3810. doi: 10.1121/1.5133393.
   PubMed Web of Science ®Google Scholar
• Bielefeld EC, Harrison RT, DeBacker JR. Pharmaceutical otoprotection strategies to prevent impulse noise-induced hearing loss. J Acoust Soc Am. 2019;146(5):3790–3799. doi: 10.1121/1.5132285
   PubMed Web of Science ®Google Scholar
• Zhang J. Blast-induced tinnitus and its related dysfunctions: animal models. J Acoust Soc Am. 2019;146(5):3811–3831. doi: 10.1121/1.5132551
   PubMed Web of Science ®Google Scholar
• Le Prell CG, Hamill T, Murphy WJ. Noise-induced hearing loss and its prevention: integration of data from animal models and human clinical trials. J Acoust Soc Am. 2019;146(5):4051–4074. doi: 10.1121/1.5132951
   PubMed Web of Science ®Google Scholar
• Le Prell CG, Hackett TA, Ramachandran R. Noise-induced hearing loss and its prevention: current issues in mammalian hearing. Curr Opin Physiol. 2020;18:32–36. doi: 10.1016/j.cophys.2020.07.004
   PubMed Web of Science ®Google Scholar
• Themann CL, Masterson EA. Review: occupational noise exposure and hearing loss. J Acoust Soc Am. 2019;146(5):3879–3905. doi: 10.1121/1.5134465
   PubMed Web of Science ®Google Scholar
• Wartinger F, Malyuk H, Portnuff CD. Human exposures and their associated hearing loss profiles: music industry professionals. J Acoust Soc Am. 2019;146(5):3906–3910. doi: 10.1121/1.5132541
   PubMed Web of Science ®Google Scholar
• Neitzel RL, Fligor BJ. Risk of noise-induced hearing loss due to recreational sound: review and recommendations. J Acoust Soc Am. 2019;146(5):3911–3921. doi: 10.1121/1.5132287
   PubMed Web of Science ®Google Scholar
• Roberts B, Neitzel RL. Noise exposure limit for children in recreational settings: review of available evidence. J Acoust Soc Am. 2019;146(5):3922–3933. doi: 10.1121/1.5132540
   PubMed Web of Science ®Google Scholar
• Chan P, Ho K, Ryan AF. Impulse noise injury model. Mil Med. 2016;181(5 Suppl):59–69. doi: 10.7205/MILMED-D-15-00139
   PubMed Web of Science ®Google Scholar
• Lorito G, Hatzopoulos S, Laurell G, et al. Dose-dependent protection on cisplatin-induced ototoxicity - an electrophysiological study on the effect of three antioxidants in the Sprague-Dawley rat animal model. Med Sci Monit. 2011;17(8):BR179–186. doi: 10.12659/MSM.881894
   PubMed Web of Science ®Google Scholar
• Breglio AM, Rusheen AE, Shide ED, et al. Cisplatin is retained in the cochlea indefinitely following chemotherapy. Nat Commun. 2017;8(1):1654. doi: 10.1038/s41467-017-01837-1
   PubMedGoogle Scholar
• Ogier JM, Lockhart PJ, Burt RA. Intravenously delivered aminoglycoside antibiotics, tobramycin and amikacin, are not ototoxic in mice. Hear Res. 2020;386:107870. doi: 10.1016/j.heares.2019.107870
   PubMed Web of Science ®Google Scholar
• Murillo-Cuesta S, Contreras J, Cediel R, et al. Comparison of different aminoglycoside antibiotic treatments to refine ototoxicity studies in adult mice. Lab Anim. 2010;44(2):124–131. doi: 10.1258/la.2009.009046
   PubMedGoogle Scholar
• Blakley BW, Hochman J, Wellman M, et al. Differences in ototoxicity across species. J Otolaryngol Head Neck Surg. 2008;37(5):700–703.
   PubMed Web of Science ®Google Scholar
• Lough MER, Plack CJ. Extended high-frequency audiometry in research and clinical practice. J Acoust Soc Am. 2022;151(3):1944–1955. doi: 10.1121/10.0009766
   PubMed Web of Science ®Google Scholar
• Foster AC, Szobota S, Piu F, et al. A neurotrophic approach to treating hearing loss: Translation from animal models to clinical proof-of-concept. J Acoust Soc Am. 2022;151(6):3937–3946. doi: 10.1121/10.0011510
   PubMed Web of Science ®Google Scholar
• Sanchez VA, Arnold ML, Moore DR, et al. Speech-in-noise testing: Innovative applications for pediatric patients, underrepresented populations, fitness for duty, clinical trials, and remote services. J Acoust Soc Am. 2022;152(4):2336–2356. doi: 10.1121/10.0014418
   PubMed Web of Science ®Google Scholar
• Brungart DS, Sherlock LP, Kuchinsky SE, et al. Assessment methods for determining small changes in hearing performance over time. J Acoust Soc Am. 2022;151(6):3866–3885. doi: 10.1121/10.0011509
   PubMed Web of Science ®Google Scholar
• Konrad-Martin D, Poling GL, Dreisbach LE, et al. Serial monitoring of otoacoustic emissions in clinical trials. Otol Neurotol. 2016;37(8):e286–e294. doi: 10.1097/MAO.0000000000001134
   PubMed Web of Science ®Google Scholar
• Bramhall NF. Use of the auditory brainstem response for assessment of cochlear synaptopathy in humans. J Acoust Soc Am. 2021;150(6):4440–4451. doi: 10.1121/10.0007484
   PubMed Web of Science ®Google Scholar
• Trevino M, Zang A, Lobarinas E. The middle ear muscle reflex: Current and future role in assessing noise-induced cochlear damage. J Acoust Soc Am. 2023;153(1):436–445. doi: 10.1121/10.0016853
   PubMed Web of Science ®Google Scholar
• Der Biest H V, Keshishzadeh S, Keppler H, et al. Envelope following responses for hearing diagnosis: robustness and methodological considerations. J Acoust Soc Am. 2023;153(1):191–208. doi: 10.1121/10.0016807
   PubMed Web of Science ®Google Scholar
• Le Prell CG, Clavier OH, Bao J. Noise-induced hearing disorders: clinical and investigational tools. J Acoust Soc Am. 2023;153(1):711–722. doi: 10.1121/10.0017002
   PubMed Web of Science ®Google Scholar
• Brock P, Meijer A, Kogner P, et al. Sodium thiosulfate as cisplatin otoprotectant in children: the challenge of when to use it. Pediatr Blood Cancer. 2023;70(5):e30248. doi: 10.1002/pbc.30248
   PubMed Web of Science ®Google Scholar
• Freyer DR, Orgel E, Knight K, et al. Special considerations in the design and implementation of pediatric otoprotection trials. J Cancer Surviv. 2023;17(1):4–16. doi: 10.1007/s11764-022-01312-x
   PubMed Web of Science ®Google Scholar
• Butler D. Translational research: crossing the valley of death. Nature. 2008;453(7197):840–842. doi: 10.1038/453840a
   PubMed Web of Science ®Google Scholar
• Khanna I. Drug discovery in pharmaceutical industry: productivity challenges and trends. Drug Discov Today. 2012;17(19–20):1088–1102. doi: 10.1016/j.drudis.2012.05.007
   PubMed Web of Science ®Google Scholar