Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05621798
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2022-08-11
Brief Title:
Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements REM for Hearing Aid Fitting
Sponsor:
Kuopio University Hospital
Organization:
Kuopio University Hospital
Study Overview
Official Title:
Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements REM for Hearing Aid Fitting
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREM
Brief Summary:
Adjusting hearing aid users real ear performance by using probe-microphone technology real ear measurement REM has been a well-known procedure that verifies whether the output of the hearing aid at the eardrum matches the desired prescribed target Still less than half of audiologists verify hearing aid fitting to match the prescribed target amplification with this technology Recent studies have demonstrated failures to match the prescribed amplification targets using exclusively the predictions of the proprietary software American Speech-Language-Hearing Association ASHA and American Academy of Audiology AAA have created Best Practice Guidelines that recommend using real-ear measurement REM over initial fit approach and also the recent ISO 213882020 on hearing aid fitting management recommends the routine use of REM Still audiologists prefer to rely on the manufacturers default first-fit settings because of the lack of proof over cost-effectiveness and patient outcome in using REM There are only few publications of varying levels of evidence indicating benefits of REM-fitted hearing aids with respect to patient outcomes that include self-reported listening ability speech intelligibility in quiet and noise and patients preference Our main research question is whether REM-based fitting improves the patient reported outcome measures - PROMs SSQ HERE and performance-based outcome measures speech-reception threshold in noise over initial fit approach An additional research question is whether REM-based fitting improves hearing aid usage self-reported log-data report Eventually the investigators will calculate the cost-effectiveness of REM-based fitting
Detailed Description:
Adjusting hearing aid users real ear performance by using probe-microphone technology real ear measurement REM has been a well-known procedure over 30 years among audiologists With this measurement technique it is possible to verify whether the output of the hearing aid at the eardrum matches the desired prescribed target Still less than half of audiologists verify their hearing aid fitting to match the prescribed target amplification with this technology Many still rely on the manufacturers default first-fit settings initial fit approach which means that the patients hearing thresholds at any given frequency are transferred to the programming software that predicts the output and gain of the hearing aid by using proprietary or modified prescriptive algorithm These proprietary algorithms create an approximation over patients in situ hearing aid gain and output based on data such as the age of the patient an estimate of microphone location effects the ear mold or shell design and length venting size and tubing characteristics
Recent studies have demonstrated failures to match the prescribed amplification targets using exclusively the predictions of the proprietary software The American Speech-Language-Hearing Association ASHA and American Academy of Audiology AAA have created Best Practice Guidelines that recommend using real-ear measurement REM over initial fit approach in order to verify the prescribed gain and output of the hearing aids Accordingly the recent ISO 213882020 on hearing aid fitting management recommends the routine use of REM So why is REM still rarely applied clinically The main reason is the lack of proof over cost-effectiveness and patient outcome There are only few publications of varying levels of evidence indicating benefits of REM-fitted hearing aids with respect to patient outcomes that include self-reported listening ability speech intelligibility in quiet and noise and patients preference According to a very recent systematic review and meta-analyses by Almufarrij et al published in 2021 there are only six publications that meets the inclusion criteria and the evidence favors REM fitting for all outcomes reported self-reported listening ability speech intelligibility in quiet and noise and preference Still the quality of evidence varies across the outcomes since all articles had a rather limited number of participants and only two used power calculation to determine the sample size None of these studies reported health-related quality of life which was assessed to be the primary outcome by the reviewers Also secondary outcomes of interest including adverse events generic quality of life and cost-effectiveness were not assessed The authors also acknowledged the lack of sufficient follow-up duration the maximum duration was only 6 weeks and the lack of permission for further adjustment to the amplification characteristics In addition the included studies failed to investigate first-time users over experienced hearing-aid users and the amplification characteristics the experienced users were familiar with were not reported This was judged to possibly impact on short-term outcomes since changes of hearing-aid users amplification characteristics that they are already accustomed to can cause discomfort The authors also claimed that future studies should also estimate the importance of any benefit found and evaluate the reasons why participants are reporting these benefits
In summary current evidence indicates that the initial fit approach often fails to achieve the prescriptive acoustic gain and output of hearing aids however evidence which would clearly show that REM-based hearing aid fitting which is time-consuming is clinically relevant and cost-effective is lacking and thus warrants further studies
Our main research question is whether REM-based fitting improves the patient reported outcome measures - PROMs SSQ HERE and performance-based outcome measures speech-reception threshold in noise over initial fit approach These are the primary outcomes of our study An additional research question is whether REM-based fitting improves hearing aid usage self-reported log-data report Eventually the investigators will calculate the cost-effectiveness of REM-based fitting These are the secondary outcomes of our study
Recent studies have demonstrated failures to match the prescribed amplification targets using exclusively the predictions of the proprietary software The American Speech-Language-Hearing Association ASHA and American Academy of Audiology AAA have created Best Practice Guidelines that recommend using real-ear measurement REM over initial fit approach in order to verify the prescribed gain and output of the hearing aids Accordingly the recent ISO 213882020 on hearing aid fitting management recommends the routine use of REM So why is REM still rarely applied clinically The main reason is the lack of proof over cost-effectiveness and patient outcome There are only few publications of varying levels of evidence indicating benefits of REM-fitted hearing aids with respect to patient outcomes that include self-reported listening ability speech intelligibility in quiet and noise and patients preference According to a very recent systematic review and meta-analyses by Almufarrij et al published in 2021 there are only six publications that meets the inclusion criteria and the evidence favors REM fitting for all outcomes reported self-reported listening ability speech intelligibility in quiet and noise and preference Still the quality of evidence varies across the outcomes since all articles had a rather limited number of participants and only two used power calculation to determine the sample size None of these studies reported health-related quality of life which was assessed to be the primary outcome by the reviewers Also secondary outcomes of interest including adverse events generic quality of life and cost-effectiveness were not assessed The authors also acknowledged the lack of sufficient follow-up duration the maximum duration was only 6 weeks and the lack of permission for further adjustment to the amplification characteristics In addition the included studies failed to investigate first-time users over experienced hearing-aid users and the amplification characteristics the experienced users were familiar with were not reported This was judged to possibly impact on short-term outcomes since changes of hearing-aid users amplification characteristics that they are already accustomed to can cause discomfort The authors also claimed that future studies should also estimate the importance of any benefit found and evaluate the reasons why participants are reporting these benefits
In summary current evidence indicates that the initial fit approach often fails to achieve the prescriptive acoustic gain and output of hearing aids however evidence which would clearly show that REM-based hearing aid fitting which is time-consuming is clinically relevant and cost-effective is lacking and thus warrants further studies
Our main research question is whether REM-based fitting improves the patient reported outcome measures - PROMs SSQ HERE and performance-based outcome measures speech-reception threshold in noise over initial fit approach These are the primary outcomes of our study An additional research question is whether REM-based fitting improves hearing aid usage self-reported log-data report Eventually the investigators will calculate the cost-effectiveness of REM-based fitting These are the secondary outcomes of our study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None