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Wearing hearing aids has been such a positive experience for Marie Redfern, she wants to encourage others with hearing loss to try them, too. Your experience can provide helpful information to someone looking for a great hearing care provider, reward a clinic for taking good care of their patients and create a sense of community where you live.
The study, which will use patients’ stem cells from their own stored umbilical cord blood, is the first-of-its-kind, and has the potential to restore hearing. The year-long study will follow 10 children, ages 6 weeks to 18 months, who have sustained post-birth hearing loss.
Parents will be interviewed by phone to determine eligibility of their children for the study. Since more infants are surviving premature birth, physicians and researchers are seeing a rising number of very young children with significant hearing loss. According to the National Institutes of Health (NIH), approximately 4000 new cases of SSHL occur each year in the United States. While SSHL characterizations remain varied, the NIH defines the condition as an idiopathic hearing loss of sensorineural origin, greater than 30 dB in three contiguous frequencies that occurs in less than three days.
In the idiopathic camp, there are a number of possible causal ideologies at work-vascular, viral, genetic, lifestyle, and disease-related causes, Dr. There is a strong link to the genetic and lifestyle ideologies and a much weaker one to viral and vascular, Dr.
With regard to incidence and prevalence of direct effect SSHL, he said both were hard to quantify because the data are such that a reliable denominator is not available.
Top of pageAbstractNoise, chemicals and genetic defects are all common causes of irreversible hearing loss, which at present have no cure. Top of pageIntroductionThe cochlea contains two types of sensory cells, inner hair cells (IHC) and outer hair cells (OHC), which carry out the transduction of sounds to electrical signals. This journal is a member of and subscribes to the principles of the Committee on Publication Ethics.
Middle ear implants are available to hearing-impaired patients who are dissatisfied with conventional hearing aids.
The Vibrant Soundbridge is a semi-implantable device that has been FDA approved for the treatment of sensorineural hearing loss.
The Vibrant Soundbridge utilizes a hearing technology that directly drives the ossicular chain (middle ear bones), bypassing the ear canal and tympanic membrane. The externally-worn receiver, called the Audio Processor™ (approximately the size of a quarter). The Soundbridge is a direct drive device which mechanically vibrates the bones in the middle ear without surgically altering the structures of the middle ear. The tiny Floating Mass Transducer™, attached to the incus bone in the middle ear, is approximately the size of a grain of rice. The external audio processor picks up the sound from the environment and transmits it across the skin to the receiver of the VORP.
The Soundbridge is not a cochlear implant and it is not currently approved for conductive hearing loss.
Hearing aids, which are worn in the ear canal, amplify sound acoustically in order to increase the movement of the eardrum and indirectly vibrate the middle ear bones. With nothing in the ear canal, the Soundbridge is a particularly good treatment option for current hearing aid wearers who suffer from occlusion or feedback, and those who are looking for better sound quality or improved cosmetics. The procedure to implant the Soundbridge is done on an outpatient basis and it takes approximately one and a half to two hours.
Many private insurance companies-- HMO, PPO, or fee for service -- cover the Soundbridge implant procedure. This follows evidence from published laboratory studies that cord blood helps repair damaged organs in the inner ear. Those who meet the criteria will be admitted to Children’s Memorial Hermann Hospital to undergo a series of blood tests, hearing and speech tests, and an MRI that will view the tracts that send signals from the inner ear to the brain. The cells then will be given to the patients via IV infusion and patients will be observed for several hours in the hospital. Despite much attention, even a definitive definition of the malady escapes researchers, making successful therapies even harder to uncover. It can affect anyone, but for unknown reasons it happens most often to people between the ages of 30 and 60.
SSHL occurs most often in people between ages 30 and 60; a number of causal ideologies have been proposed.
Direct effect deals with things we know caused the hearing loss-largely loud noise, trauma, or toxins.
Gene therapy may soon be utilized in both the protection and the treatment of these exogenous and endogenous sources of hearing loss. These signals are transmitted to the auditory pathway of the brain via spiral ganglion neurons (SGCs). The Vibrant Soundbridge has been shown to be a safe alternative to hearing aids in people with sensorineural, or nerve hearing loss who cannot or do not wish to wear a hearing aid.
It is 100 percent digital and is programmed by an Audiologist eight weeks after the implant procedure to fit the user's specific hearing loss. The signal is then transmitted to the Floating Mass Transducer (FMT) causing it to vibrate. Cochlear implants are for the estimated 10 percent of the hearing-impaired population who suffer from severe to profound hearing loss. In contrast, the Soundbridge provides an enhanced signal to the inner ear by directly vibrating the middle ear bones while leaving the ear canal open and the eardrum undisturbed. For many patients who cannot wear hearing aids due to medical necessity, a middle ear implant like the Soundbridge is the only available alternative. Occlusion is the sensation of hearing distorted, muffled sounds experienced when an object blocks the ear canal. Implant patients are exposed to the normal risks of middle ear surgery and general anesthesia.
Maw for the treatment of conductive and mixed hearing losses, which can occur in patients with chronic disease of the middle ear.
To ensure consistency in cord blood stem cell processing, storage and release for infusion, CBR is the only stem cell bank providing clients for the study.
In an effort to spur discussion and a possible movement toward consensus, an international panel gathered to examine the epidemiology of SSHL and discuss traditional treatment modalities at the recent American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) annual meeting here.The experts also wheeled out some of the more promising research and cutting-edge treatment modalities available. Hoffer, MD, of the Naval Medical Center in San Diego, said that, in addition, the root causes of SSHL could be broken into two separate types-idiopathic and direct effect. Basically, someone gets blown up, they get a hearing loss and we know it was direct effect. The vascular hypothesis comes from a Japanese study showing subjects had an increased incidence of SSHL when switching from a traditionally Japanese diet to an American diet.This showed promise at the time, Dr.


Gene therapy technology is rapidly developing and the inner ear is a particularly feasible model for gene therapy. Unfortunately, neither of these sensory or primary neural cells have the capacity to regenerate. It is currently the only middle ear implant approved by the FDA for the treatment of hearing loss. The Soundbridge is indicated for use in adults, 18 years or older, with a moderate to severe sensorineural hearing loss and no interest in conventional hearing aids. The Soundbridge converts sound into mechanical energy which is directly transmitted to the auditory ossicles. They are implanted directly in the inner ear, or cochlea, where they electronically stimulate the nerves through a series of electrodes. It is a common complaint among hearing aid users, who often find that the presence of the hearing aid, or hearing aid ear mold, in their ear canal distorts not only outside sounds but also the sound of their own voice. It can be placed at the opening to the inner ear, the round window, bypassing the middle ear bones which may be absent or diseased, and therefore eliminates the conductive, or mechanical hearing loss of the ear. Hoffer said, but when combined with other, similar research, it became clear that genetic causes were at play.
This review outlines our current understanding of the mechanisms behind deafness and prospects for treatment, discusses the inner ear model in detail and reviews the efforts that have been made in inner ear gene therapy.
It is manufactured by the Med El Corporation and over 2300 patients have been implanted internationally.
Maw was an investigating surgeon of the FDA trail for sensorineural hearing loss, and implanted 14 patients with the device during the clinical trial. The Soundbridge is the first FDA approved implantable middle ear hearing device to treat sensorineural hearing loss.. In contrast, the Soundbridge is implanted in the middle ear and is for the 60 percent of hearing-impaired people with moderate-to-severe sensorineural hearing loss. It can also amplify sound to overcome a sensorineural, or nerve hearing loss, if also present. Eustachian tube dysfunction limits the hearing results that patients can achieve with reconstructive ear surgery, and there are no well-established treatments for this problem.
He also said viral ideology research is conflicting and cannot be reproduced, but that he is still convinced there has to be some kind of infectious variable at work.
Despite recent developments in medicine, there are still no clinically useful means for curing hearing disorders and protecting auditory function.
A proven, safe and effective treatment that leaves the ear canal completely open, the Soundbridge features a 94 percent improvement in patient satisfaction, with thousands of patients worldwide. As this device can mimic the function of the middle ear, we can potentially help a large category of patients who could not be previously considered as suitable surgical candidates”.
It is of paramount importance to develop novel and effective methods of treating both inherited and acquired hearing loss.
This device is an excellent choice for patients experiencing difficulty with their own voice quality due to occlusion, feedback or reverberation issues with conventional hearing aids. The Soundbridge is intended for use in adults (18 years or older) who have moderate-to-severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. The mastoid bone is opened and the middle ear is then entered through the mastoid and the floating mass transducer is placed on the incus. Gene therapy technology has improved in recent years, making it a promising technique for treating such inner ear disorders. It is also beneficial for patients who are experiencing multiple hearing aid repairs due to debris or cerumen or someone interested in a more comfortable hearing solution. The hair cells provide stimuli to the auditory nerve, which is interpreted as sound by the brain. The inner ear holds several unique advantages as a model for gene therapy.Firstly, the cochlea is anatomically well suited for in vivo gene therapy.
This is a clinical scenario that is frequently encountered by ear surgeons, and is often caused by poor function of the Eustachian tube, the tube which connects the middle ear to the back of the nose.
The relative isolation of the cochlear compartments minimizes unwanted effects of the introduced gene into other tissues. Protection and treatment of sensorineural hearing disorders caused by exogenous factors: experimental findings and potential clinical application. The inner ear is fluid-filled, allowing all functionally important cells to be accessed by a transfection reagent. The concentration and dosage of complexes introduced to the cochlea can easily be modulated with a single injection or longer infusion by an osmotic pump. At activation, the device is connected to the Siemens programming software and programmed for the individual’s hearing loss.
Cochlear endolymph and perilymph volumes have been characterized in the guinea pig, rat and mouse, so adverse effects of high volume and pressure can be avoided.Secondly, various physiological measurement tools have been developed to monitor the function of specific cells (Table 1), and thus assess the efficacy and safety of gene therapy.
Cochlear Microphonics (CM) and Otoacoustic emission (OAE) measurements are useful in assessing the state of damage of OHCs.
Local application of sodium thiosulfate prevents cisplatin-induced hearing loss in the guinea pig. Detection of Endocochlear Potentials (EPs) helps to determine the presence of endolymphatic ion balances. Sequence of exposure to noise and toluene can determine loss of auditory sensitivity in the rat. Over 90 different genes have now been identified that affect inner ear development or function, as well as many loci known to be involved in deafness.
Dose and time-dependent protection of the antioxidant N-L-acetylcysteine against impulse noise trauma. Neurotrophic factors are essential in the development of the inner ear and in the protection of the adult inner ear sensory cells against ototoxic chemical and noise induced damage.3 Neurotrophin gene therapy is promising both in the protection against exogenous damage and the regeneration after endgenous and exogenous damage. Neurotrophins can be applied through in vivo inoculation of vectors carrying their genes or more indirectly through gene therapy-modified stem cells.Top of pageExogenous and endogenous causes of deafnessMany antibiotic and anticancer drugs are ototoxic.
Antioxidants attenuate gentamicin-induced free radical formation in vitro and ototoxicity in vivo: D-methionine is a potential protectant. Aminoglycoside antibiotics have been successfully used in the treatment of various infectious diseases for more than 40 years. Those who suffer from NIHL also tend to have increased vulnerability to chemical ototoxic insults.8Approximately one in 800 children are born with a severe to profound genetic-related hearing loss (GRHL). Gene therapy is the most promising solution for curing them.Top of pageMechanisms of peripheral hearing loss and prospects for treatmentThe underlying mechanisms of sensorineural hearing loss are not completely understood. We do, however, have working hypothesies for surmounting these challenges through gene therapy. The following is an outline of likely mechanisms and how they can be prevented and treated.Reactive oxygen species (ROS) and antioxidantsSignificant ROS generated in the reduction of oxygen to water include the superoxide anion, hydrogen peroxide and the hydroxyl radical.


Complementary roles of neurotrophin 3 and a N-methyl-D-aspartate antagonist in the protection of noise and aminoglycoside-induced ototoxicity.
Miller et al18 demonstrated the enhancement of SGC survival after the kanamycin and ethacrynic acid-induced loss of IHCs, through the chronic infusion of BDNF into the cochlea.
This is important because the success of cochlear implant treatment depends on the presence of SGCs at the site of the implant. Cochlear implant therapy could be improved by applying neurotrophins to the human cochlea.Top of pageMonitoring auditory function after gene therapyGene delivery systems must not be cytotoxic, and cells must be able to return to a normal physiological state after treatment.
First, ABR responses to sound input are used to noninvasively record activity in all the parts of the auditory pathway, allowing for a long-term survey. Using an electrode placed on the round window, the CAP method yields more sensitive results than the ABR. Various OAE measurements noninvasively assess the properties of cochlear sound amplification related to OHC function.
All of these techniques can be used to evaluate the recovery of auditory function after an invasive surgery or after gene delivery. Additionally, an evaluation of the Stria Vascularis can be performed through the study of EPs. The use of EPs in assessing early anomalies in the scala media could be of particular use in future Meniere's Disease animal models.Top of pageIntroducing gene therapy vectors into the cochleaThe cochlea, encased by bone, is divided into three fluid compartments called scalae. The scala vestibuli and scala tympani (Figure 1) contain a high-sodium, low-potassium perilymph. Overexpression of Math1 induces robust production of extra hair cells in postnatal rat inner ears.
A cochleostomy, a small hole in the cochlear bone, can be made for access to the scala tympani.
Both of these methods have been shown to deliver drugs effectively without hindering rodent cochlear function.15, 16, 20 The cochleostomy is advantageous in gene transfer efficacy, while the RW method is less invasive. Intrathecal injection of HJV-E containing HGF gene to cerebrospinal fluid can prevent and ameliorate hearing impairment in rats. Recently, the placement of gelfoam-soaked therapeutics on the RW was shown useful in the delivery of certain vectors.21 The vestibular superior semicircular canal can also be accessed via a canalostomy.
They are easy to prepare, can be complexed with DNA of any size, and have a very low risk of insertional mutagenesis. Liposome complexed with LacZ and GFP reporter genes have successfully transfected nearly all tissue types of mice and guinea pig cochleae in vivo.22, 23, 24Evidence has not shown clinically useful transfection efficiencies. A broader investigation of vectors and promoters, and the incorporation of nuclear localization sequences and targeting ligands could result in an efficient vector. Better insight into cell membrane composition and nuclear transport may also result in improvements.
A modified adenovirus can transfect cochlear hair cells in vivo without compromising cochlear function. Other methods such as electroporation25 and the gene gun26 have yielded significant in vitro results but have not been developed for effective use in vivo.Another concept is the nonviral vector with virally derived fusion activity.
The hemaglutinating virus of Japan envelope vector recently transfected more than 70 percent of SGCs without affecting ABR performances, after injection to the cisterna magna.27 The injection method raises issues such as dissemination beyond the cochlea,28 but this vector may prove more efficient than other nonviral vectors and safer than viral vectors. This variation may result from variation in Ad concentrations, Ad vector generations, and methods of vector inoculation and transgenic protein detection.
The mechanisms involved in Ad transfection need to be elucidated, ideally through a study of the expression of Ad receptors in the inner ear.Recent studies have used the Ad vector to prevent deafness in animals.
Adenovirus-mediated overexpression of a gene prevents hearing loss and progressive inner hair cell loss after transient cochlear ischemia in gerbils.
It has also been shown to protect OHCs from gentamicin ototoxicity,30 in a study where Ad infection of hair cells was not shown.
Pre-emptive gene therapy using recombinant adeno-associated virus delivery of extracellular superoxide dismutase protects heart against ischemic reperfusion injury, improves ventricular function and prolongs survival.
The reason for the protective effect is unknown, but may be attributed to the secretion of proteins. Cytotoxicity has been found in many inner ear studies, likely a consequence of this immune response. Preliminary attempts to address these immune responses have been carried out with two types of immunosuppressants: T-lymphocyte costimulator inhibitors and the anti-inflammatory steroids.
Adenoviral and adeno-associated viral vector mediated gene transfer in the guinea pig cochlea. In the cochlea, HSV vectors transfect primarily SGCs.22, 41 NT-3 stimulates the survival of auditory neurons. Long-term in vivo cochlear transgene expression mediated by recombinant adeno-associated virus. Cochlear function and transgene expressio in the guinea pig cochlea, using adenovirus- and adeno-associated virus-directed gene transfer. HSV research is in a developmental stage for inner ear applications, but holds potential in promoting neuronal cell survival.LentiviralUnlike other retroviral vectors, lentiviral vectors (LVs) can infect nondividing cells. Neurotrophin-3 transduction attenuates cisplatin spiral ganglion neuron ototoxicity in the cochlea.
Less accessible cells such as the spiral ganglia and glial cells have been transfected in vitro.42 Based on these early studies, the potential uses for this vector involve the secretion of growth factors and antibiotics into the perilymph. The possibility of insertional mutagenesis must be carefully studied in the inner ear before seriously considering this vector for clinical use. Transgene expression in the guinea pig cochlea mediated by a lentivirus-derived gene transfer vector.
The insertion of genes into the chromosome is also advantageous, however, in the potential treatment of genetic hearing loss.
Methods have been developed for the inoculation of vectors into the cochlea as well as the detection of gene products and the assessment of cochlear function. As previously described, neurotrophins promote the survival of and delay the degeneration of SGCs.
Neurotrophin gene therapy performed in conjunction with cochlear implant surgery would likely enhance neurite growth to the cochlear implant. The performance of cochlear implants is contingent on the presence and function of these neurons. Specifically, stem cells with genes for neurotrophins NT-3, BDNF, GDNF, VEGF should be infused into the cochlea of deaf animals, to promote in vivo differentiation of the stem cells into sensory, supporting and neural cells in the cochlea.




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