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Auditory Neuropathy

Disease/Condition(s): Auditory neuropathy
What is Auditory Neuropathy?

Auditory neuropathy is a hearing disorder where sound enters the inner ear normally, but the transmission of signals from the inner ear to the brain is impaired. This condition occurs due to damage or dysfunction in the auditory nerve fibers or inner hair cells of the cochlea, leading to a disruption in the timing and clarity of sound transmission. Individuals with auditory neuropathy may experience hearing loss, difficulty understanding speech, especially in noisy environments, and fluctuating hearing abilities. Diagnosis typically involves audiometric tests and auditory brainstem response (ABR) testing, which reveal normal outer hair cell function but abnormal neural responses.

Auditory Neuropathy Sponsored Testing Program Overview:

Auditory Neuropathy (Resonate)

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What is the role of testing for Auditory Neuropathy?

Every year, thousands of children are born with disabling hearing loss and the majority of cases of congenital hearing loss are due to an underlying genetic cause. However, few individuals receive a genetic diagnosis and a key barrier is the availability and accessibility of genetic testing.

A genetic diagnosis may lead to better insight to help guide medical management and decision making, as well as determine potential eligibility for clinical studies or future clinical trials.

The Resonate program provides genetic testing for eligible individuals with auditory neuropathy. To help understand their genetic testing results, program participants in the United States also have access to optional genetic counseling provided through the program by InformedDNA, at no cost to participants, their insurance, or their healthcare providers.

What is the Program?

Resonate® is a no-charge genetic testing and counseling program for sensorineural hearing loss, sponsored by Akouos, Inc. Resonate uses a comprehensive panel of nearly 300 genes to potentially determine whether there is an underlying genetic cause of hearing loss. U.S. healthcare providers can order directly through PreventionGenetics; alternatively, providers (including audiologists) can refer patients to genetic counselors at InformedDNA who can provide pre- and post-test counseling and ordering of sponsored sensorineural hearing loss genetic testing. Providers will receive a genetic testing report and a report from the genetic counselor (if applicable).

Program Eligibility

  • Individuals under 40 years of age in the U.S. with at least one of the following:
    • Bilateral sensorineural hearing loss (by auditory brainstem response or behavioral testing) of moderate, moderately severe, severe, or profound degree
    • Auditory neuropathy
  • Individuals under 18 years of age in Brazil or Mexico with at least one of the following:
    • Bilateral sensorineural hearing loss (by auditory brainstem response or behavioral testing) of severe or profound degree
    • Auditory neuropathy

Testing

How to participate

Choose between the following testing options:

Prevention Genetics

The Resonate Program Panel

Genes Evaluated: A2ML1, ABHD12, ABHD5, ACOX1, ACTB, ACTG1, ADCY1, ADGRV1, AIFM1, ALMS1, ANLN, AP1B1, ARSB, ARSG, ASIC5, ATOH1, ATP11A, ATP1A3, ATP2B2, ATP6V1B1, BCAP31, BCS1L, BDP1, BSND, BTD, CABP2, CACNA1D, CATSPER2, CCDC50, CD151, CD164, CDC14A, CDH23, CEACAM16, CEP250, CEP78, CHD7, CIB2, CISD2, CLDN14, CLDN9, CLIC5, CLPP, CLRN1, CLRN2, COCH, COL11A1, COL11A2, COL1A1, COL2A1, COL4A3, COL4A4, COL4A5, COL4A6, COL9A1, COL9A2, COL9A3, CRYM, DBH, DCAF17, DCDC2, DIABLO, DIAPH1, DIAPH3, DMXL2, DNAJC3, DNMT1, DSPP, DTNA, EDN3, EDNRA, EDNRB, EFTUD2, ELMOD3, EPS8, EPS8L2, ERAL1, ESPN, ESRRB, EYA1, EYA4, FDXR, FGF3, FGFR3, FITM2, FOXC1, FOXI1, GALNS, GATA3, GDF6, GIPC3, GJA1, GJB1, GJB2, GJB3, GJB6, GLB1, GNS, GPRASP2, GPSM2, GRAP, GREB1L, GRHL2, GRXCR1, GRXCR2, GSDME, GUSB, HARS1, HARS2, HGF, HGSNAT, HOMER2, HOXA2, HSD17B4, HYAL1, IDS, IDUA, IFNLR1, ILDR1, JAG1, KARS1, KCNE1, KCNJ10, KCNQ1, KCNQ4, KITLG, LARS2, LHFPL5, LHX3, LMX1A, LOXHD1, LOXL3, LRP2, LRTOMT, MAFB, MAN2B1, MAP1B, MARVELD2, MCM2, MEOX1, MEPE, MET, MINAR2, MIR96, MITF, MPZ, MPZL2, MRPS2, MSRB3, MYH14, MYH7B, MYH9, MYO15A, MYO18B, MYO3A, MYO6, MYO7A, NAGLU, NARS2, NDP, NDRG1, NF2, NLRP3, NOG, OPA1, OSBPL2, OTOA, OTOF, OTOG, OTOGL, P2RX2, PAX3, PCDH15, PCGF2, PDE1C, PDZD7, PEX1, PEX10, PEX11B, PEX12, PEX13, PEX14, PEX16, PEX19, PEX2, PEX26, PEX3, PEX5, PEX6, PEX7, PHYH, PI4KB, PJVK, PLEC, PLS1, PLS3, PMP22, PNPT1, POLR1C, POLR1D, POU3F4, POU4F3, PRKCB, PRPS1, PTPRQ, RAI1, RDX, REEP6, REST, RIPOR2, RMND1, ROR1, RPS6KA3, S1PR2, SCP2, SEMA3E, SERAC1, SERPINB6, SGSH, SH3TC2, SIX1, SIX2, SIX5, SLC12A2, SLC17A8, SLC22A4, SLC26A4, SLC26A5, SLC29A3, SLC44A4, SLC4A11, SLC52A2, SLC52A3, SLC9A1, SLITRK6, SMARCA4, SMPX, SNAI2, SOX10, SPNS2, STRC, SYNE4, TBC1D24, TBX1, TCOF1, TECTA, TFAP2A, TIMM8A, TJP2, TMC1, TMEM126A, TMEM132E, TMEM43, TMIE, TMPRSS3, TNC, TPRN, TRIOBP, TRMT10C, TRRAP, TSHZ1, TSPEAR, TUBB4B, TWNK, UBR1, USH1C, USH1G, USH2A, VCAN, WBP2, WFS1, WHRN, XYLT2, and ZNF469

How To Order

Either order the test using akouosresonate.preventiongenetics.com or refer for genetic counseling, plus test ordering using InformedDNA.

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FAQs

Program Information

What is the purpose of the Resonate program?

The Resonate program aims to improve access to genetic testing for individuals of any age with a clinical diagnosis of auditory neuropathy or a medical history consistent with auditory neuropathy. It provides genetic testing at no cost to the participants, helping to guide medical management and potentially determine eligibility for clinical trials.

What type of support does the Resonate program offer besides genetic testing?

In addition to genetic testing, the Resonate program offers optional genetic counseling to help participants understand their genetic testing results. This counseling is provided through InformedDNA in the United States and includes a comprehensive review of medical and family history, interpretation of identified genetic variants, and medical management recommendations.

How can someone participate in the Resonate program?

Eligibility for the program requires having a current or previous clinical diagnosis of auditory neuropathy or a medical history consistent with auditory neuropathy. Interested participants should contact their healthcare provider, who can then order the test through Prevention Genetics.

What does the genetic testing panel include?

The genetic testing in the Resonate program uses the Prevention Genetics Resonate panel, which includes 274 genes associated with genetic forms of hearing loss.

Is there a cost to participate in the Resonate program?

No, there is no cost to the participants, their insurance, or healthcare providers for participating in the Resonate program. The program is designed to be accessible and remove financial barriers to genetic testing for auditory neuropathy.

More Information About This Program

  • Patients that meet the eligibility criteria may receive one test at no cost.
  • No patients, providers, and/or third-party payers (including commercial health plans and government health care programs) will be billed for the testing covered under the program.
  • The ordering physician will not receive any fees or other compensation in connection with the Sponsored Testing Program, such as for specimen collection, handling, or data reporting.
  • Patients meeting the above eligibility criteria, as well as their treating health care providers, are not required to order, purchase, prescribe, and/or obtain any other product or service from sponsor, the labs or any of their affiliates.
  • The performing labs reserve the right to rescind, revoke, or amend the program for any reason without notice.
  • Program is not valid where prohibited by law.
  • No identifiable patient data will be shared with sponsor as part of this program.

About Akouos

Akouos Logo

Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. www.akouos.com

About Eli Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY

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